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DewDiligence

09/24/15 3:06 PM

#195280 RE: genisi #192402

CHMP endorses GSK’s Nucala (mepolizumab) for COPD:

http://in.reuters.com/article/2015/09/24/us-gsk-asthmadrug-idINKCN0RO1PO20150924
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DewDiligence

11/04/15 8:04 PM

#196850 RE: genisi #192402

FDA approves GSK’s Nucala (mepolizumab) for asthma:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm471031.htm

The U.S. Food and Drug Administration today approved Nucala (mepolizumab) for use with other asthma medicines for the maintenance treatment of asthma in patients age 12 years and older. Nucala is approved for patients who have a history of severe asthma attacks (exacerbations) despite receiving their current asthma medicines.

In the EU, Nucala has been endorsed by the CHMP and is awaiting rubber-stamping by the EU Commission (#msg-117234259).