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ARTICLE | Company News

FDA panel backs Teva's reslizumab for adults

December 10, 2015 2:35 AM UTC

FDA's Pulmonary- Allergy Drugs Advisory Committee voted 11-3 that efficacy and safety data support approval of reslizumab from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) to treat asthma in adults. The committee voted 14-0 against approval for the humanized mAb against IL-5 in patients aged 12-17. Reslizumab's PDUFA date is in March 2016.

Teva is seeking approval of reslizumab to reduce exacerbations, relieve symptoms and improve lung function in patients aged 12 and older with asthma and elevated blood eosinophils who are inadequately controlled on inhaled corticosteroids. ...