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Details:
Otezla® (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP), indicated for the treatment of plaque psoriasis in adults.
Lead Product(s): Apremilast
Therapeutic Area: Dermatology Product Name: Otezla
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 19, 2023
Details:
16-week data demonstrated clinically meaningful and statistically significant improvement in genital psoriasis, with twice many patients achieving primary endpoint of clear (0) or almost clear (1) sPGA-G scale receiving Otezla (apremilast) when compared with placebo.
Lead Product(s): Apremilast
Therapeutic Area: Dermatology Product Name: Otezla
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 September 08, 2022
Details:
Presentations will cover a range of clinical data for Otezla® (apremilast), including positive, 16-week results from the Phase 3 SPROUT study in children ages 6-17 with moderate to severe plaque psoriasis.
Lead Product(s): Apremilast
Therapeutic Area: Dermatology Product Name: Otezla
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 August 30, 2022
Details:
New data further reinforces clinical benefit of Otezla (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 in mild to moderate plaque psoriasis and in patients with palmoplantar pustulosis.
Lead Product(s): Apremilast
Therapeutic Area: Dermatology Product Name: Otezla
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 25, 2022
Details:
The adverse events observed in the trial were consistent with the known safety profile of Otezla. The most commonly reported (≥5%) treatment-emergent adverse events with Otezla treatment were diarrhea, headache, nausea and nasopharyngitis.
Lead Product(s): Apremilast
Therapeutic Area: Dermatology Product Name: Otezla
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 20, 2021
Details:
Zydus Pharmaceuticals (USA) Inc. has received final approval from the US Food and Drug Administration (FDA) to market apremilast tablets in the strengths of 10 mg, 20 mg, 30 mg tablets are indicated for treatment of adult patients with plaque psoriasis.
Lead Product(s): Apremilast
Therapeutic Area: Dermatology 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 September 24, 2021
Details:
Otezla® (apremilast) has potential to be first and only approved oral therapy for the mild-to-moderate patient population. Acceptance based on data from Phase 3 ADVANCE Study, demonstrating clinically meaningful improvements through week 32.
Lead Product(s): Apremilast
Therapeutic Area: Dermatology Product Name: Otezla
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 05, 2021
Details:
The company has received tentative approval from US Food and Drug Administration for its abbreviated new drug application (ANDA) Apremilast tablets in the strengths of 10 mg, 20 mg, and 30 mg, Shilpa Medicare said in a regulatory filing.
Lead Product(s): Apremilast
Therapeutic Area: Immunology 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 March 05, 2021
Details:
The sNDA is based on data from the Phase 3 ADVANCE trial that demonstrated oral Otezla 30 mg twice daily achieved a statistically significant improvement in the primary endpoint of the static Physician's Global Assessment (sPGA) response at week 16 compared to placebo.
Lead Product(s): Apremilast
Therapeutic Area: Dermatology Product Name: Otezla
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 February 22, 2021
Details:
Unichem Laboratories has received ANDA approval for its Apremilast Tablets, 10 mg, 20 mg and 30 mg from the United States Food and Drug Administration (USFDA) to market a generic version of Amgen’s Otezla® (apremilast) Tablets, 10 mg, 20 mg, and 30 mg.
Lead Product(s): Apremilast
Therapeutic Area: Dermatology 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 February 19, 2021
Details:
Amgen & Eisai to participate in the immune modulation domain of REMAP-COVID, an adaptive clinical trial to test interventions for patients hospitalized with COVID-19. Amgen’s Apremilast & Eisai’s Eritoran to be evaluated across multiple international trial sites.
Lead Product(s): Apremilast,Eritoran,Hydrocortisone
Therapeutic Area: Infections and Infectious Diseases Product Name: Otezla
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 27, 2020
Details:
Oral Otezla 30 mg twice daily achieved a statistically significant improvement, compared with placebo in mild-to-moderate Psoriasis.
Lead Product(s): Apremilast
Therapeutic Area: Dermatology 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 06, 2020
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