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FDA Accepts Review for New COPD Indication of GSK’s Nucala®

Dec 9, 2024

On 9 December 2024, GSK announced that the US FDA has accepted for review data to support a new indication for the use of Nucala® (mepolizumab) as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype.  The data is from the MATINEE study, which demonstrated that treatment of COPD with Nucala® resulted in a statistically significant and clinically meaningful reduction of the annualised rate of moderate/severe exacerbations versus placebo with patients treated for 52-104 weeks.

On the same day, GSK also announced that China’s National Medical Products Administration (NMPA) has accepted for review a new drug application (NDA) for Blenrep® (belantamab mafodotin) in combination with BorDex (bortezomib plus dexamethasone) as a treatment for relapsed or refractory multiple myeloma.