FDA Committee Recommends Approval of Teva's Asthma Drug

Teva is encouraged after their reslizumab, a biotech treatment for specific group of patients with inadequately controlled asthma, is recommended for the FDA approval.

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Teva's headquarters in Jerusalem.
Teva's headquarters in Jerusalem.Credit: Bloomberg
Tova Cohen

REUTERS - Israel-based Teva Pharmaceutical Industries said on Thursday the U.S. Food and Drug Administration's pulmonary-allergy drugs advisory committee had recommended approval of reslizumab in patients aged 18 and over.

Reslizumab, an antibody, is a biologic therapy for the treatment of inadequately controlled asthma in patients with elevated eosinophils in their blood despite use of an inhaler.

"We are very encouraged by the outcome of today's FDA advisory committee meeting, which brings us one step closer to potentially providing a new, targeted treatment option for a specific group of patients with inadequately controlled asthma," said Michael Hayden, chief scientific officer at Teva.

"This group of patients often experiences persistent symptoms despite standard-of-care treatment."

The committee's recommendation will be considered by the FDA in its review of the biologics license application for reslizumab. The FDA is not bound by the committee's recommendation, but takes its advice into consideration when reviewing investigational medicines.