GSK plc announced that the China National Medical Products Administration has accepted for review a new drug application for Nucala as an add-on maintenance treatment for severe eosinophilic asthma, or SEA. "If approved, Nucala would be the first targeted anti-Interleukin-5 (IL-5) treatment in China for adult and adolescent patients with this condition. The application is based on positive data from a phase III trial among Chinese patients and the global SEA development programme, which included three key clinical trials – DREAM, MENSA and SIRIUS – that established the efficacy and safety profile of mepolizumab for severe eosinophilic asthma patients. The 52-week phase III trial in Chinese patients studied the effect of mepolizumab as adjunctive therapy in patients with SEA with a primary endpoint of reduction, relative to placebo, in the annual rate of clinically significant exacerbations. The efficacy and safety of mepolizumab in the Chinese population were shown to be consistent with that in a non-Chinese population with SEA," the company stated.
Confident Investing Starts Here:
- Quickly and easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions
- Receive undervalued, market resilient stocks straight to you inbox with TipRanks' Smart Value Newsletter
Published first on TheFly
See the top stocks recommended by analysts >>
Read More on GSK:
- GSK says FDA Advisory Committee supports effectiveness and safety of RSV vaccine
- GSK Pharma put volume heavy and directionally bearish
- FDA Virtual Vaccines & Related Biological Products Advisory Committee Meeting
- GSK reinstated with a Buy at Goldman Sachs
- GlaxoSmithKline Slips after a New Look into Zantac Risk