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Drugs in Development
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 Brand Name: Takhzyro
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2023
Lead Product(s) : Lanadelumab
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
The European Commission Approves Label Update for TAKHZYRO® (lanadelumab), Expanding Its Use to a...
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.
Brand Name : Takhzyro
Molecule Type : Large molecule
Upfront Cash : 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 Brand Name: Takhzyro
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 22, 2023
Lead Product(s) : Lanadelumab
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Takhzyro
Molecule Type : Large molecule
Upfront Cash : 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 Brand Name: Takhzyro
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 03, 2023
Lead Product(s) : Lanadelumab
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
U.S. FDA Approves Takeda’s TAKHZYRO® (lanadelumab-flyo) to Prevent Hereditary Angioedema (HAE) ...
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.
Brand Name : Takhzyro
Molecule Type : Large molecule
Upfront Cash : 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 Brand Name: Takhzyro
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 05, 2022
Lead Product(s) : Lanadelumab
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
U.S. Food and Drug Administration Accepts Takeda’s Supplemental Biologics License Application fo...
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.
Brand Name : Takhzyro
Molecule Type : Large molecule
Upfront Cash : 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 Brand Name: Takhzyro
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 01, 2022
Lead Product(s) : Lanadelumab
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Takeda’s TAKHZYRO Shows Positive Results in the Prevention of HAE Attack
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.
Brand Name : Takhzyro
Molecule Type : Large molecule
Upfront Cash : 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 Brand Name: Takhzyro
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 12, 2022
Lead Product(s) : Lanadelumab
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
TAKHZYRO® (lanadelumab) Open Label Phase 3 Study Met its Objectives in Children Ages 2 to <12 Yea...
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 adminis...
Brand Name : Takhzyro
Molecule Type : Large molecule
Upfront Cash : 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 Brand Name: Takhzyro
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 28, 2022
Lead Product(s) : Lanadelumab
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Takeda’s TAKHZYRO® (lanadelumab) Approved in Japan for Prophylaxis Against Acute Attacks of Her...
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.
Brand Name : Takhzyro
Molecule Type : Large molecule
Upfront Cash : 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 Brand Name: Takhzyro
Study Phase: Phase IVProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 28, 2022
Lead Product(s) : Lanadelumab
Therapeutic Area : Genetic Disease
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Interim Phase 4 Data Support TAKHZYRO® (lanadelumab) as an Effective Treatment to Reduce Attacks ...
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.
Brand Name : Takhzyro
Molecule Type : Large molecule
Upfront Cash : 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 Brand Name: Takhzyro
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 05, 2021
Lead Product(s) : Lanadelumab
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Takhzyro
Molecule Type : Large molecule
Upfront Cash : 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 Brand Name: Takhzyro
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 10, 2021
Lead Product(s) : Lanadelumab
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Data from the Phase 3 HELP Study™ Evaluating TAKHZYRO to be Presented at EAACI
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.
Brand Name : Takhzyro
Molecule Type : Large molecule
Upfront Cash : Not Applicable
July 10, 2021
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