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