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Details:
The drug Olumiant (baricitinib) has received restricted emergency use approval from the Central Drugs Standard Control Organization (CDSCO), for use in combination with remdesivir for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults.
Lead Product(s): Baricitinib,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Olumiant
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Eli Lilly
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement May 11, 2021
Details:
Under the agreement, Aclaris granted Lilly non-exclusive rights under patents and patent applications that Aclaris exclusively licenses from The Trustees of Columbia University, for the use of Olumiant (baricitinib), Lilly’s JAK inhibitor, to treat alopecia areata (AA).
Lead Product(s): Baricitinib
Therapeutic Area: Dermatology Product Name: Olumiant
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Eli Lilly
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement August 25, 2022
Details:
Across the studies at 36 weeks, 17-22% of patients taking OLUMIANT (baricitinib), 2 mg/day and 32-35% of patients taking OLUMIANT 4-mg/day achieved 80% or more scalp hair coverage, compared to 3-5% taking placebo.
Lead Product(s): Baricitinib
Therapeutic Area: Dermatology Product Name: Olumiant
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Incyte Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 14, 2022
Details:
Achievement of full regrowth or regrowth with minimal gaps in eyebrow and eyelash hair also seen at 36 weeks with OLUMIANT (baricitinib) 4-mg for 1 in 3 patients who at baseline had significant gaps or no notable eyebrows or eyelashes, as compared to patients taking placebo.
Lead Product(s): Baricitinib
Therapeutic Area: Dermatology Product Name: Olumiant
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 20, 2022
Details:
OLUMIANT (baricitinib) is the first and only JAK inhibitor FDA-approved for the treatment of COVID-19 in certain hospitalized adults requiring various degrees of oxygen support.
Lead Product(s): Baricitinib,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Olumiant
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Incyte Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 11, 2022
Details:
Adults with severe alopecia areata (AA) who took OLUMIANT® (baricitinib) achieved significant scalp, eyelash and eyebrow hair regrowth and nearly 75% of those who responded to OLUMIANT 4-mg achieved 90% scalp coverage at 52 weeks.
Lead Product(s): Baricitinib
Therapeutic Area: Dermatology Product Name: Olumiant
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Incyte Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 26, 2022
Details:
OLUMIANT was the first JAK inhibitor approved to treat moderate-to-severe patients with atopic dermatitis who have an inadequate response to topical treatments in the European Union and Japan.
Lead Product(s): Baricitinib
Therapeutic Area: Dermatology Product Name: Olumiant
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Incyte Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 28, 2022
Details:
Among those treated with OLUMIANT, the overall incidence rate of adverse events per 100 patient years of exposure was 22.6, and the incidence rate of serious adverse events was 7.4. Incidence rates remained stable over time across the 14,744 patient years of exposure.
Lead Product(s): Baricitinib
Therapeutic Area: Immunology Product Name: Olumiant
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Incyte Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2021
Details:
OLUMIANT, a once-daily, oral JAK inhibitor was discovered by Incyte and licensed to Lilly. It is approved in the U.S. and more than 75 countries as a treatment for adults with moderate to severe rheumatoid arthritis.
Lead Product(s): Baricitinib
Therapeutic Area: Dermatology Product Name: Olumiant
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Incyte Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 30, 2021
Details:
Baricitinib, an oral JAK inhibitor discovered by Incyte and licensed to Lilly, is approved for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) in more than 75 countries.
Lead Product(s): Baricitinib
Therapeutic Area: Dermatology Product Name: Olumiant
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Incyte Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 16, 2021
Details:
Baricitinib will only be included in the randomisation of women of child-bearing potential if they have had a negative pregnancy test since admission.
Lead Product(s): Baricitinib
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: University of Oxford
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 14, 2021
Details:
Baricitinib provides greater improvements in patient-reported outcomes across all disease activity levels compared to placebo and adalimumab in rheumatoid arthritis.
Lead Product(s): Baricitinib
Therapeutic Area: Immunology Product Name: Olumiant
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Incyte Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2021
Details:
Lupin has signed a royalty-free, limited, non-exclusive voluntary licensing agreement with Eli Lilly and Company (Lilly) for manufacturing and selling of Lilly’s drug Baricitinib in India.
Lead Product(s): Baricitinib,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Olumiant
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Lupin Ltd
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement May 10, 2021
Details:
Sun Pharma has entered into a royalty-free, non-exclusive voluntary licensing agreement with Eli Lilly and Company (“Lilly”) for expanding access to Lilly’s drug, baricitinib in India. Sun Pharma will manufacture and distribute the drug in India.
Lead Product(s): Baricitinib,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Olumiant
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sun Pharmaceutical Industries Limited
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement May 10, 2021
Details:
Natco Pharma has filed for a waiver of patent rights to manufacture rheumatoid arthritis drug Baricitinib. The CL, if granted, will help in improving the accessibility and affordability of the drug, bringing its price down substantially.
Lead Product(s): Baricitinib
Therapeutic Area: Infections and Infectious Diseases Product Name: Olumiant
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 06, 2021
Details:
Natco Pharma has received Emergency Use approval for Baricitinib tablets, 1mg, 2mg and 4mg strengths from Central Drugs Standard Control Organization (CDSCO) in India. Baricitinib, in combination with Remdesivir, is used for treatment of COVID-19-positive patients.
Lead Product(s): Baricitinib,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 03, 2021
Details:
EMA’s human medicines committee (CHMP) will carry out an accelerated assessment of data submitted by the company that markets Olumiant, including results from 2 large randomised studies in patients hospitalised with COVID-19.
Lead Product(s): Baricitinib
Therapeutic Area: Infections and Infectious Diseases Product Name: Olumiant
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 29, 2021
Details:
Olumiant is an immunosuppressant (a medicine that reduces the activity of the immune system). It is currently authorised for use in adults with moderate to severe rheumatoid arthritis or atopic dermatitis (eczema).
Lead Product(s): Baricitinib
Therapeutic Area: Infections and Infectious Diseases Product Name: Olumiant
Highest Development Status: Phase II/ Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 29, 2021
Details:
In one BREEZE-AD5 analysis, OLUMIANT provided concurrent improvements in the severity and extent of AD, other key symptoms and quality of life as early as one week, as measured by percent change from baseline compared to placebo.
Lead Product(s): Baricitinib
Therapeutic Area: Dermatology Product Name: Olumiant
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Incyte Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 23, 2021
Details:
Results from two studies (BRAVE-AA1 and BRAVE-AA2) show statistically significant improvement in scalp hair regrowth across both baricitinib dosing groups, compared to placebo.
Lead Product(s): Baricitinib
Therapeutic Area: Dermatology Product Name: Olumiant
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 20, 2021
Details:
The trial's goal is to see which of two drug combinations—baricitinib plus remdesivir or dexamethasone plus remdesivir—is more effective at preventing hospitalisation in patients with COVID-19 progressing to mechanical ventilation or death, among other outcomes.
Lead Product(s): Baricitinib,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Olumiant
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 15, 2021
Details:
Baricitinib-treated patients were 2.7 percent less likely than those receiving standard of care to progress to ventilation (non-invasive or mechanical) or death, a difference that was not statistically significant.
Lead Product(s): Baricitinib
Therapeutic Area: Infections and Infectious Diseases Product Name: LY3009104
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Incyte Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 08, 2021
Details:
U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for baricitinib for the treatment of adults with moderate to severe atopic dermatitis (AD).
Lead Product(s): Baricitinib
Therapeutic Area: Dermatology Product Name: LY3009104
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Incyte Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 06, 2021
Details:
Both doses of baricitinib met the primary efficacy endpoint at Week 36, demonstrating a statistically significant improvement in scalp hair regrowth compared to those randomized to placebo.
Lead Product(s): Baricitinib
Therapeutic Area: Dermatology Product Name: LY3009104
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Incyte Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 03, 2021
Details:
Baricitinib in combination with remdesivir provided a faster median recovery time and reduced progression to ventilation or death compared to remdesivir alone in hospitalized COVID-19 patients on oxygen.
Lead Product(s): Baricitinib,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Olumiant
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: National Institutes of Health
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 11, 2020
Details:
Results of the study demonstrated baricitinib in combination with remdesivir provided a faster median recovery time and reduced progression to ventilation or death compared to remdesivir alone in hospitalized COVID-19 patients on oxygen.
Lead Product(s): Baricitinib,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Olumiant
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 11, 2020
Details:
The EUA is based on data from the ACTT-2, a randomized double-blind, placebo-controlled study to evaluate the efficacy and safety of baricitinib in combination with remdesivir vs placebo with remdesivir in hospitalized patients with or without oxygen requirements.
Lead Product(s): Baricitinib,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Olumiant
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Incyte Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 19, 2020
Details:
In the study, the patients, who were in multiple hospitals across Italy and Spain, had a 71 per cent reduced risk of dying compared to patients who had not taken the drug (baricitinib).
Lead Product(s): Baricitinib
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 13, 2020
Details:
The Subject Expert Committee (SEC) that advises the drug regulatory authority on new drugs, vaccines for Covid gave its permission to the company in a meeting held on November 4.
Lead Product(s): Baricitinib
Therapeutic Area: Infections and Infectious Diseases Product Name: Olumiant
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 05, 2020
Details:
New data for baricitinib for the treatment of moderate to severe atopic dermatitis showed that baricitinib 4-mg and 2-mg dose groups were able to maintain clear or almost clear skin response rates through the 68-week treatment period.
Lead Product(s): Baricitinib
Therapeutic Area: Dermatology Product Name: Olumiant
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Incyte Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 31, 2020
Details:
Data support baricitinib's ongoing Phase 3 program and potential to be the first approved medicine for people living with alopecia areata (AA).
Lead Product(s): Baricitinib
Therapeutic Area: Dermatology Product Name: Olumiant
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Incyte Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 30, 2020
Details:
Baricitinib in combination with remdesivir reduced time to recovery and improved clinical outcomes for patients with COVID-19 infection compared with remdesivir. 35% decrease in death rate through Day 29 was observed in patients treated with baricitinib plus remdesivir.
Lead Product(s): Baricitinib,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Olumiant
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Incyte Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 08, 2020
Details:
If approved, baricitinib would become the first JAK inhibitor indicated to help treat patients with AD. The positive opinion was based on Phase 3 BREEZE-AD clinical development program evaluating the baricitinib potential to treat AD including BREEZE-AD1 and BREEZE-AD2.
Lead Product(s): Baricitinib
Therapeutic Area: Dermatology Product Name: Olumiant
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Incyte Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 18, 2020
Details:
The randomised control trial included more than 1,000 patients and began on May 8 to assess the efficacy and safety of baricitinib plus remdesivir versus remdesivir in hospitalised patients with COVID-19.
Lead Product(s): Baricitinib
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: DiscoveryProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 14, 2020
Details:
Baricitinib in combination with remdesivir met the primary endpoint of reduction of time to recovery in comparison with remdesivir.
Lead Product(s): Baricitinib,Remdesivir
Therapeutic Area: Infections and Infectious Diseases Product Name: Olumiant
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: National Institutes of Health
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 14, 2020
Details:
First patient has been enrolled in a Phase 3 randomized, double-blind, placebo–controlled study to evaluate the efficacy and safety of baricitinib, an oral JAK1/JAK2 inhibitor licensed from Incyte, in hospitalized adults with COVID-19.
Lead Product(s): Baricitinib
Therapeutic Area: Infections and Infectious Diseases Product Name: Olumiant
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2020
Details:
Highlights from Olumiant data being presented at the virtual meeting include new long-term data in patients living with rheumatoid arthritis (RA) as well as data from an investigational trial in patients with systemic lupus erythematosus (SLE).
Lead Product(s): Baricitinib
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 03, 2020
Details:
Researchers at Montefiore Health System and Albert Einstein College of Medicine in the US have started a clinical trial to assess antiviral drug remdesivir plus rheumatoid arthritis medication baricitinib to treat hospitalised patients with severe Covid-19.
Lead Product(s): Remdesivir,Baricitinib
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: NIH
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 27, 2020
Details:
The clinical trial is the next iteration of NIAID’s Adaptive COVID-19 Treatment Trial, which began on Feb. 21 to evaluate Gilead's remdesivir.
Lead Product(s): Remdesivir,Baricitinib
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 08, 2020
Details:
Physicians from Keck Medicine of USC are set to launch a clinical trial to study the effects of an anti-inflammatory drug on treating patients with moderate to severe coronavirus (Covid-19).
Lead Product(s): Baricitinib
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 07, 2020
Details:
The study will investigate the efficacy and safety of baricitinib as a potential treatment for hospitalized patients diagnosed with COVID-19.
Lead Product(s): Baricitinib
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Eli Lilly
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement April 10, 2020
Details:
The recognition reinforces baricitinib's potential to be the first FDA-approved medicine for individuals living with alopecia areata.
Lead Product(s): Baricitinib
Therapeutic Area: Dermatology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 16, 2020
Details:
Results of rapid sequencing of the new coronavirus, coupled with molecular modeling based on the genomes of related virus proteins, have suggested Baricitinib to be effective.
Lead Product(s): Baricitinib
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 05, 2020
Details:
Study met primary endpoint of at least 75% improvement of skin inflammation. Safety profile was consistent with the known safety findings of baricitinib in atopic dermatitis.
Lead Product(s): Baricitinib,Corticosteroid
Therapeutic Area: Dermatology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 27, 2020
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