FDA panel backs GSK’s severe asthma therapy

GlaxoSmithKline (GSK) is on course for US approval of its mepolizumab candidate after an FDA advisory committee voted unanimously in favour of its use in adults with severe asthma.

The panel recommended against its approval in children aged 12 to 17, however – by a margin of 10 votes to four – concluding that there was a lack of data in this group.

Nevertheless, the positive verdict for the drug as an add-on therapy for patients with breakthrough symptoms of asthma caused by eosinophil immune cells puts GSK in pole position to bring a drug in the interleukin-5 antagonist class to market in the US, ahead of rivals such as AstraZeneca’s benralizumab and Teva’s reslizumab.

Eosinophilic asthma affects around a third of all patients with the respiratory disorder and it can be hard to control symptoms using standard drugs such as bronchodilators and corticosteroids. At the moment patients typically need long-term steroid therapy, which can cause side effects such as weight gain and high blood pressure.

If the FDA follows its committee’s advice and approves the drug by the review deadline of 4 November, mepolizumab will become the first therapy specifically approved for eosinophilic asthma.

“These are patients who currently have very few treatment options and our belief in this medicine as a new treatment option has today been reinforced by the advisory committee’s decision,” said GSK’s president of R&D Patrick Vallance.

“GSK will continue to work closely with the FDA to complete the review of the biologics licence application for mepolizumab,” he added.

Mepolizumab is one of the new product candidates GSK is hoping will restore the fortunes of its respiratory franchise, which has suffered of late from generic competition and downward pricing pressure on flagship asthma and chronic obstructive pulmonary disorder (COPD) product Advair/Seretide (salmeterol/fluticasone).

Newer inhaled therapies such as Anoro (vilanterol/umeclidinium) and Breo (vilanterol/fluticasone furoate) have yet to show evidence that they will make up the shortfall in Advair revenues, which are set to plummet once the drug faces generic competition in the US.

Mepolizumab could help pick up the slack, according to analysts, who note the IL-5 inhibitors and other new biologic therapies for asthma, such as Regeneron/Sanofi’s IL-4 and IL-13 blocker dupilumab and AZ’s anti-IL-13 antibody tralokinumab, as a whole could eventually bring in sales of more than $7 billion at peak.

GSK filed for approval of mepolizumab in Japan earlier this month and the drug is also under regulatory review in the EU, where it was filed last November.

Approximately 5 per cent of patients with severe asthma cannot achieve symptom control with existing therapies, according to GSK.

Related article

Mylan debuts generic Seretide in UK

Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.