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Novartis AG Receives FDA Therapy Designation For BYM338 For Sporadic Inclusion Body Myositis


Tuesday, 20 Aug 2013 01:16am EDT 

Novartis AG announced that it receives FDA therapy designation for BYM338 (bimagrumab) for sporadic inclusion body myositis (sIBM) . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement. Breakthrough therapy designation was created by the FDA to expedite the development and review of new drugs for serious or life-threatening conditions. This designation is based on the results of a Phase II proof-of-concept study that showed BYM338 substantially benefited patients with sIBM compared to placebo. The results of this study will be presented at the American Neurological Association meeting on October 14 and is expected to be published in a medical journal later this year. 

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