Pulmonary-Allergy Drugs Advisory Committee (PADAC)

On Wednesday, December 9, 2015, the Pulmonary-Allergy Drugs Advisory Committee (PADAC) supported, by a vote of 11-Yes to 3-No, with no abstentions, the safety and efficacy of 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 with asthma and elevated blood eosinophils, who are inadequately controlled on inhaled corticosteroids. The Committee did not support, by a vote of 0-Yes to 14-No, with no abstentions, the drug’s proposed use to treat adolescents, those aged 12-17 years, with asthma and elevated blood eosinophils, who are inadequately controlled on inhaled corticosteroids.