GlaxoSmithKline's asthma injection heads for EU approval

GSK's Dave Allen

GlaxoSmithKline ($GSK) got a positive opinion from European regulators on its new treatment for severe asthma, setting the stage for a likely approval later this year.

GSK's injection, mepolizumab, works by blocking the protein interleukin-5 to prevent buildups of white blood cells in the lungs that can exacerbate asthma. The company is angling to get the drug approved around the world as a treatment for sufferers of severe asthma who aren't getting the relief they need from inhaled therapies.

The European Medicines Agency has recommended approving the drug for adults whose asthmatic symptoms persist despite taking inhaled corticosteroids and another controlling treatment. That recommendation now goes to the European Commission, which commonly hands down an approval within three months.

"For these difficult-to-treat patients there are very limited treatment options," GSK respiratory head Dave Allen said in a statement. "Many struggle to control their asthma even when taking high doses of inhaled therapies and are often reliant on daily oral corticosteroids, which can cause serious long-term side effects."

Meanwhile, GSK is expecting to pick up U.S. approval for mepolizumab by Nov. 4 after winning a positive vote from a panel of FDA advisers in June. The agency's panel voted against recommending the antibody for treatment of children but, like its European counterpart, unanimously supported mepolizumab's use in adults.

GSK is leading a pack of drugmakers developing IL-5 antibodies for severe asthma, including AstraZeneca ($AZN) and its Phase III benralizumab, plus Teva ($TEVA), which plans to file its similar reslizumab this year. All three contenders are working to prove their antibodies can improve results in COPD as well, hoping to carve out a new market for injectable respiratory treatments that analysts have said could reach above $7 billion a year.

- read the statement