Details:
Nucala (mepolizumab) is the first-in-class monoclonal antibody to target IL-5. It is believed to work by preventing IL-5 from binding to its receptor on the surface of eosinophils, reducing blood eosinophils and maintaining them within normal levels.
Lead Product(s): Mepolizumab
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Nucala
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 01, 2023
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 III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 14, 2022
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 III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 10, 2020
Details:
This is the first time an anti-IL5 biologic has reported positive phase 3 data in CRSwNP, and adds to the range of eosinophil-driven diseases in which Nucala has efficacious data.
Lead Product(s): Mepolizumab
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 03, 2020