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Details:
Fasenra (benralizumab) is now approved by the US Food and Drug Administration (FDA) for add-on maintenance treatment for patients with severe asthma aged 6 to 11 with an eosinophilic phenotype. Previously it was approved in same indication for patients aged 12 and older.
Lead Product(s): Benralizumab
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Fasenra
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 11, 2024
Details:
FASENRA (benralizumab) is a monoclonal antibody that binds directly to IL-5 receptor alpha on eosinophils and attracts natural killer cells to induce rapid and near-complete depletion of blood and tissue eosinophils in most patients via apoptosis.
Lead Product(s): Benralizumab
Therapeutic Area: Gastroenterology Product Name: Fasenra
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 September 11, 2023
Details:
Fasenra (benralizumab) is a monoclonal antibody that binds directly to IL-5 receptor alpha on eosinophils and attracts natural killer cells to induce rapid and near-complete depletion of blood and tissue eosinophils in most patients via apoptosis.
Lead Product(s): Benralizumab
Therapeutic Area: Gastroenterology Product Name: Fasenra
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 25, 2022
Details:
The sBLA submitted to FDA by AstraZeneca included data from OSTRO Phase III trial for Fasenra (benralizumab), an mAB that binds directly to IL-5 receptor alpha on eosinophils met both co-primary endpoints with a safety profile consistent with known profile of medicine.
Lead Product(s): Benralizumab,Mometasone Furoate
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Fasenra
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 March 14, 2022
Details:
Benralizumab (Fasenra) is indicated as an add-on maintenance treatment for severe asthma with an eosinophilic phenotype in adult patients.
Lead Product(s): Benralizumab
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Fasenra
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 22, 2021
Details:
The company has received approval from the DCGI for Fasenra (Benralizumab solution for injection in a single dose prefilled syringe30 mg/ml) for patients with severe asthma (eosinophilic asthma).
Lead Product(s): Benralizumab
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Fasenra
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 22, 2020
Details:
Fasenra showed a statistically significant improvement in the endoscopic total nasal polyp score and the nasal blockage score compared to placebo, in patients with severe bilateral nasal polyposis who were still symptomatic despite continued treatment with standard of care.
Lead Product(s): Benralizumab,Mometasone Furoate
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Fasenra
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 September 10, 2020
Details:
AstraZeneca has revealed positive results from a Phase IIIb trial of Fasenra (benralizumab) in severe eosinophilic asthma patients.
Lead Product(s): Benralizumab
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Fasenra
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 06, 2020
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