FDA Alert: Monoclonal Antibodies (mAb) to Target Interleukin-5 (IL-5)

Teva Pharmaceutical Industries Ltd., announced that the Food and Drug Administration (FDA) has accepted a biologics license application for reslizumab. FDA Regulatory Action is expected in March 2016.

In other FDA news, the FDA Pulmonary Allergy Drugs Advisory Committee has recommended approval of GlaxoSmithKline Plc's drug mepolizumab (known as Nucala) for severe asthma in patients aged 18 and older. The panel voted 10 to 4 against approving it in children aged 12 to 17. The FDA is not obliged to follow the advice of its advisory panels but typically does so.

The biologics license application for mepolizumab was submitted to the FDA in November 2014 for approval as an add-on maintenance treatment for patients with severe asthma with eosinophilic inflammation, identified by a blood eosinophil count of at least 150 cells per microliter at the start of treatment or 300 cells per microliter in the past 12 months.

Both mepolizumab and reslizumab are monoclonal antibodies (mAb) which target interleukin-5 (IL-5), for the treatment of poorly controlled asthma in adult and adolescent patients with elevated blood eosinophils, despite an inhaled corticosteroid (ICS)-based regimen.

There are currently no products designed to treat patients based on predefined eosinophil levels. If approved, Reuters reports that mepolizumab could be the first new biologic treatment for severe asthma in more than a decade.