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Details:
Takhzyro (lanadelumab-flyo) is a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein activity and is indicated for prophylaxis to prevent attacks of HAE in patients aged 12 years and older.
Lead Product(s): Lanadelumab
Therapeutic Area: Genetic Disease Product Name: Takhzyro
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2023
Details:
Takhzyro (lanadelumab-flyo) is a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein activity and is indicated for prophylaxis to prevent attacks of HAE in patients aged 12 years and older.
Lead Product(s): Lanadelumab
Therapeutic Area: Genetic Disease Product Name: Takhzyro
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 22, 2023
Details:
Takhzyro (lanadelumab-flyo) is a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein activity and is indicated for prophylaxis to prevent attacks of HAE in patients 2 years of age and older.
Lead Product(s): Lanadelumab
Therapeutic Area: Genetic Disease Product Name: Takhzyro
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 03, 2023
Details:
TAKHZYRO® (lanadelumab-flyo) Injection is a prescription medicine used to prevent attacks of hereditary angioedema (HAE) in people 12 years of age and older.
Lead Product(s): Lanadelumab
Therapeutic Area: Genetic Disease Product Name: Takhzyro
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 05, 2022
Details:
TAKHZYRO® (Lanadelumab-flyo) Injection is a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein and is indicated for routine prevention of recurrent attacks of HAE in patients aged 12 years and older.
Lead Product(s): Lanadelumab
Therapeutic Area: Genetic Disease Product Name: Takhzyro
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 01, 2022
Details:
TAKHZYRO is a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein and is indicated for routine prevention of recurrent attacks of HAE in patients aged 12 years and older. TAKHZYRO is formulated for subcutaneous administration.
Lead Product(s): Lanadelumab
Therapeutic Area: Genetic Disease Product Name: Takhzyro
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 12, 2022
Details:
The approval is primarily based on results of global Phase 3 HELP Study™ and the Phase 3 HELP Study Open-label Extension (OLE), in addition to results of a Phase 3 study evaluating the efficacy and safety of TAKHZYRO in Japanese patients.
Lead Product(s): Lanadelumab
Therapeutic Area: Genetic Disease Product Name: Takhzyro
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 28, 2022
Details:
The observational Phase 4 EMPOWER study, evaluating real-world HAE attack rates before and after treatment with TAKHZYRO in patients with HAE types I and II, is ongoing. Full results of the EMPOWER study are expected to be published in 2024.
Lead Product(s): Lanadelumab
Therapeutic Area: Genetic Disease Product Name: Takhzyro
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 28, 2022
Details:
The study results show that preventative treatment with TAKHZYRO markedly reduced the frequency of hereditary angioedema (HAE) attacks in patients 12 years of age and older who received treatment for a mean duration of almost 2.5 years.
Lead Product(s): Lanadelumab
Therapeutic Area: Genetic Disease Product Name: Takhzyro
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 05, 2021
Details:
An additional analysis further suggests TAKHZYRO was a well-tolerated treatment that prevented HAE attacks over an extended planned 132 week treatment period across specific HAE patient demographic and disease characteristic subgroups.
Lead Product(s): Lanadelumab
Therapeutic Area: Genetic Disease Product Name: Takhzyro
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 10, 2021
Details:
A range of therapeutics will be evaluated for their potential efficacy and safety relative to the condition severity of patients hospitalized with COVID-19, this includes Takeda’s investigational intravenous administration of lanadelumab, Amgen’s OTEZLA® and UCB’s zilucoplan.
Lead Product(s): Lanadelumab
Therapeutic Area: Infections and Infectious Diseases Product Name: Takhzyro
Highest Development Status: UndisclosedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 01, 2020
Details:
Results were consistent with the safety and efficacy of TAKHZYRO in the pivotal trial. The HELP Study OLE was designed to evaluate the long-term safety (primary endpoint) and efficacy of TAKHZYRO for up to 2.5 years.
Lead Product(s): Lanadelumab
Therapeutic Area: Genetic Disease Product Name: Takhzyro
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 13, 2020
Details:
Data from the Phase 3 HELP Study™ Open-label Extension suggest that TAKHZYRO® (lanadelumab) is well-tolerated and can prevent hereditary angioedema (HAE) attacks over an extended treatment period, with sustained and consistent reduction in monthly attack rates.
Lead Product(s): Lanadelumab
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 06, 2020
Details:
The pre-filled syringe presentation is designed to enhance the treatment administration experience for HAE patients receiving TAKHZYRO.
Lead Product(s): Lanadelumab
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 29, 2020
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