Logo

GSK Reports the NMPA Acceptance of NDA for Nucala (mepolizumab) to Treat Severe Eosinophilic Asthma

Share this
GSK

GSK Reports the NMPA Acceptance of NDA for Nucala (mepolizumab) to Treat Severe Eosinophilic Asthma

Shots:

  • The NMPA has accepted an NDA for review of Nucala as an add-on maintenance treatment for sev. eosinophilic asthma. The application was based on the P-III trial in Chinese patients & global SEA development program incl. three trials i.e., (DREAM 2), (MENSA3) & (SIRIUS4) evaluating mepolizumab
  • The 52wk. P-III trial investigated mepolizumab's effect as an adjunctive therapy with a 1EPs of reduction in the annual rate of clinically significant exacerbations while efficacy & safety were consistent with the non-Chinese population
  • If Nucala is approved, it will be 1st targeted anti-IL-5 treatment in China for adult & adolescent patients. The therapy was approved in the US, the EU & ~25 other markets as an add-on maintenance treatment for SEA

Ref: GSK | Image: GSK

Related News:- Bio-Thera Reports First Patient Dosing in P-I Study of BAT2606, a Proposed Biosimilar of Nucala (mepolizumab) for Severe Asthma

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions