FDA
17th December 2015

FDA Panel Endorses Reslizumab for the Treatment of Severe Asthma

Last week, the FDA’s Pulmonary and Allergy Drugs Advisory Committee (PADAC) recommended the approval of reslizumab for the treatment of moderate to severe asthma in adults.

FDA Panel Endorses Reslizumab for the Treatment of Severe Asthma

Last week, the FDA’s Pulmonary and Allergy Drugs Advisory Committee (PADAC) recommended the approval of reslizumab for the treatment of moderate to severe asthma in adults.

The committee voted 11 to 3 in favor of the safety data supporting the drug’s approval at a dose of 3 mg/kg by intravenous injection, once every 4 weeks. However, the Agency rejected the approval of the drug for use in children aged 12 to 17 years, voting unanimously 14 to 0.

Teva Pharmaceutical Industries Ltd sought approval of the monoclonal antibody injection for the reduction of exacerbation, relief of symptoms and improved lung function in people 12 years and older with asthma and elevated blood eosinophils for which inhaled corticosteroids are inadequate.

The question regarding whether the efficacy data showed clinically meaningful benefit for adults, resulted in 13 yes votes and 1 no. The same question resulted in 14 no votes with respect to children.

During the meeting, a strong need for treatment options in this specific patient population was expressed by committee members as well as the FDA. “It is estimated about 5% of the asthma population has severe asthma with an eosinophilic phenotype despite being on maximum therapy, and many of these patients are on oral corticosteroids are still uncontrolled,” explained Banu Karimi-Shah, MD, clinical team leader with the FDA’s Division of Pulmonary, Allergy, and Rheumatology Products (DPARP).

Furthermore, “patients with severe uncontrolled asthma are more likely to experience frequent asthma exacerbations and hospitalizations because of asthma. Thus, development of safe and effective therapies targeted to this subpopulation is an important therapeutic step in improving asthma outcomes,” said Dr Karimi-Shaw.

The agency is not obligated to follow its panel’s recommendation, but normally does so.

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