FDA to review Teva asthma biologic

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The US Food and Drug Administration has agreed to carry out a review on Teva’Pharmaceutical Industries’ biologic reslizumab as a potential treatment for asthma.

Specifically the Israeli drugmaker is seeking approval for reslizumab, a humanised monoclonal antibody which targets interleukin-5, as a treatment of inadequately controlled asthma in patients with elevated levels of blood eosinophils despite therapy with an inhaled corticosteroid (ICS)-based regimen.

Michael Hayden, head of R&D at Teva, noted that despite currently available medicines, “uncontrolled asthma remains a serious problem”.  In clinical trials, patients on reslizumab showed significant reductions in the rate of asthma exacerbations and significant improvement in lung function.

If approved, “we believe reslizumab will serve as an important new targeted treatment option,” he said. The FDA is expected to give its verdict by March next year.

GSK’s mepolizumab backed

The news came days after an FDA advisory committee voted 14-0 that efficacy and safety data for GlaxoSmithKline’s IL-5 inhibitor mepolizumab support the drug’s approval in adults. However, the biologic’s use in adolescents aged 12-17 with severe asthma was not backed by the panel (4 yes, 10 no).