GSK gets FDA approval of first anti-IL-5 injectable for asthma

GlaxoSmithKline ($GSK) secured FDA approval for Nucala, an injectable treatment for asthma, a therapeutic area dominated by inhaled drugs. Still, the alternative form of drug delivery for respiratory conditions has the potential to reach sales of $7 billion a year, according to analysts.

Nucala is administered subcutaneously every four weeks into the thigh, upper arm or abdomen, and targets the cell signaling protein interleukin-5 (IL-5), which regulates inflammatory cells known as eosinophils. Its active ingredient is the novel monoclonal antibody mepolizumab.

The medicine has a pretty restrictive label, which gives it an addressable market of 300,000 to 400,000 patients. Nucala was approved as an add-on maintenance treatment for severe asthma in patients with a history of attacks, the FDA said. According to Glaxo, the other first-line medications should include high-dose inhaled corticosteroids and at least one other therapy, such as oral corticosteroids.

"Following today's approval, GSK can now offer, as part of our overall respiratory portfolio, a first-in-class biologic treatment for severe asthma patients whose condition is driven by eosinophilic inflammation," said Eric Dube, the head of GSK's global respiratory franchise, in a company statement. "Our research has allowed us to better understand the specific role eosinophils play in severe asthma. We are proud of our contribution to this emerging area of science that has led to the approval of the first anti-IL5 treatment. We aim to offer this medicine to patients as soon as possible."

Novartis ($NVS) and Genentech's Xolair is another second-line injectable med for (moderate-to-)severe asthma on the market, and will be among Nucala's largest competitors. Xolair does not specifically target eosinophilic inflammation, however.

AstraZeneca's ($AZN) Phase III injectable benralizumab has the same anti-IL-5 mechanism of action as Nucala. And Teva ($TEVA) has said it plans to file this year for approval of its similar reslizumab, so direct competition is on the way.

All three players competing in the emerging injectable frontier will look to expand their med's indications to include COPD as well.

- read FierceBiotech's take and FiercePharmaMarketing's take
- read the FDA release and GSK's release