FDA advisory committee recommends approval of Teva’s reslizumab asthma drug for adults

Reslizumab is a humanized IgG4K monoclonal antibody that binds to anti interleukin 5 (IL-5).

The FDA will consider the advisory committee’s recommendation in its review of the biologics license application (BLA) for reslizumab.

The agency accepted for standard review the BLA with regulatory action is anticipated in March next year.

Reslizumab targets IL-5, a cytokine which involves in the maturation, activation and survival of eosinophils.

ThePhase III Breath clinical trial program demonstrated that reslizumab, in comparison to placebo, reduced asthma exacerbation rates by nearly half and provided better improvement in lung function and other secondary measures of asthma control when added to an existing ICS-based therapy.

Teva Pharmaceutical Industries president of global R&D and chief scientific officer Michael Hayden said in a joint statement: "Patient stratification based on eosinophil levels has been an important advancement in the treatment of asthma.

"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 and evidence of ongoing eosinophilic inflammation."

Last month, the FDA approved a similar asthma drug, Nucala (mepolizumab), which is manufactured by GlaxoSmithKline, for patients age 12 and older.