FDA Asks GSK for More Evidence of Mepolizumab’s Ability to Help Treat Flares in COPD Patients

GlaxoSmithKline’s application for approval of mepolizumab as an add-on therapy to reduce exacerbations in patients with chronic obstructive pulmonary disease (COPD) requires more clinical data, the U.S. Food and Drug Administration (FDA) said in a complete response letter.

GSK sought approval for mepolizumab as an add-on to inhaled corticosteroid-based maintenance treatments used to control flares in COPD patients with high levels of a type of white blood cell that can inflame the lungs.

The FDA’s position follows the recommendation of its Pulmonary Allergy Drugs Advisory Committee, which voted in July that mepolizumab’s  risk-benefit profile was not adequate to support its approval.

A majority of the committee’s members, 16 of the 19, voted against recommending approval due to lack of substantial evidence of effectiveness. They also suggested that additional research is needed to characterize the specific patient population who would most likely benefit from treatment with mepolizumab.

But a majority (17 of 19) also agreed that the evidence supported the therapy’s safety.

According to a press release, GSK will now work closely with the FDA regarding next steps for its supplementary biologics license application (sBLA), a request for permission to introduce a biologic drug into the market.

Mepolizumab is an antibody against interleukin (IL)-5, a small signaling molecule that controls the production, activation, and recruitment of eosinophils, a type of white blood cell.

At excessive levels, eosinophils can cause inflammation in the lungs, leading to excess sputum production and contributing to the worsening of respiratory symptoms in people with COPD. COPD patients with high eosinophil levels are known to be at greater risk of exacerbations.

Mepolizumab has been studied in 16 different clinical trials across several diseases characterized by high levels of eosinophils.

The therapy, sold as Nucala, is approved in the U.S., Europe, and 20 other countries as an add-on injection treatment for severe eosinophilic asthma.

It is also approved as an add-on treatment in the U.S., Canada, and Japan for patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare disease associated with severe asthma.

Mepolizumab is not approved anywhere for use as a COPD treatment. Besides COPD, mepolizumab is currently being investigated to treat severe hypereosinophilic syndrome, a group of rare conditions associated with high levels of eosinophils.