DEC 9 PADAC

Background Analysis: US FDA Advisory Committee to Review Teva’s Reslizumab for Eosinophilic Asthma – DEC 9, 2015 (PADAC)

The US FDA has scheduled a meeting of the Pulmonary-Allergy Drugs Advisory Committee (PADAC) for Wednesday, December 9, 2015. The Committee will discuss biologics license application (BLA) 761033, reslizumab for injection, submitted by Teva Pharmaceutical Industries, Ltd. (Teva), for the proposed indication to reduce exacerbations, relieve symptoms, and improve lung function in adults and adolescents 12 years of age and older, with asthma and elevated blood eosinophils, who are inadequately controlled on inhaled corticosteroids.

See the SAC Tracker report