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FDA approves Teva's Cinqair for asthma

March 24, 2016 12:58 AM UTC

FDA approved Cinqair reslizumab from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) as an add-on maintenance treatment of severe asthma in adults with an eosinophilic phenotype. Teva said it plans to launch the humanized mAb against IL-5 next quarter. Spokesperson Michelle Larkin declined to discuss the drug's price.

In December, FDA's Pulmonary-Allergy Drugs Advisory Committee voted 11-3 that efficacy and safety data supported Cinqair's approval to treat asthma in adults. The committee voted 14-0 against approval in patients aged 12-17. Teva sought approval of Cinqair to reduce exacerbations, relieve symptoms and improve lung function in asthma patients aged 12 and older. ...