GSK's Nucala Accepted for New Drug Application Review in China
14 March 2023 - 6:47PM
Dow Jones News
By Joe Hoppe
GSK PLC said Tuesday that its Nucala add-on maintenance
treatment for adults with severe eosinophilic asthma, or SEA, has
been accepted for a new drug application in China.
The pharmaceutical giant said that if the China National Medical
Products Administration approves the drug for use treating SEA, it
would be the first targeted treatment in China for adults and
adolescents with the condition.
The application is based on positive data from a Phase 3 trial
program among Chinese patients and the global SEA development
program, which included three key clinical trials that established
the efficacy and safety profile of the drug.
Asthma affects an estimated 46 million people in China, with 6%
experiencing severe asthma, and patients with SEA have an increased
risk of exacerbations needing hospitalization or an increased
likelihood of a potentially fatal attack.
Nucala is currently approved in China for use in adults with
eosinophilic granulomatosis with polyangiitis, and was approved in
2015 for SEA treatment in the U.S. It has since been approved in
the European Union and more than 25 other markets as an SEA
treatment.
Write to Joe Hoppe at joseph.hoppe@wsj.com
(END) Dow Jones Newswires
March 14, 2023 03:32 ET (07:32 GMT)
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