GSK seeks COPD approval for mepolizumab

GlaxoSmithKline has asked the US regulator to expand the licence of its injected lung drug mepolizumab, to include chronic obstructive pulmonary disease (COPD).

Under the brand name Nucala, mepolizumab was first approved in November 2015 as an add-on maintenance for patients with severe eosinophilic asthma aged 12 years and older.

An IL-5 antagonist, Nucala was also approved in Europe shortly after that and has proved popular with prescribers as a treatment for patients who have not responded well to existing drugs. In England, NICE also found the drug to be cost-effective.

This has led to mounting sales and in the last quarter Nucala generated revenues of £91 million for GSK, more than double the amount in the corresponding period last year.

Analysts GlobalData forecast that anti-eosinophilic biologic therapies will make up 19% of US COPD market sales in 2025. It expects Nucala to lead the field with $1.2 billion by 2025, with AstraZeneca's yet-to-be-approved benralizumab achieving sales of around $817.9 million.

This is important for GSK as it seeks to rebuild its respiratory drugs franchise, where ageing blockbuster Advair/Seretide is likely to come under threat from a US generic next year.

If the FDA approves mepolizumab as an add-on to maintenance treatment for COPD patients with an eosinophilic phenotype, this will allow GSK to get the drug well established on the market ahead of benralizumab's arrival.

Teva also has a rival IL-5 drug, Cinqair (reslizumab), approved in severe asthma and Novartis’ Xolair (omalizumab) is also considered a rival as it is approved in the same indication despite having a slightly different mechanism of action.

AstraZeneca is gearing up for the launch of benralizumab, which is currently under review by the FDA in severe eosinophilic asthma.

Also under review in Europe, AZ hopes that benralizumab will be able to take market share from its rivals thanks to an eight week dosing schedule, after an initial four-weekly interval between the first three doses.

Nucala and Cinqair are taken every four weeks, while Xolair is taken up to twice every month depending on the patient.

GSK has also filed mepolizumab in the US for adults with eosinophilic granulomatosis with polyangiitis (EGPA) – where the immune system attacks small and medium-sized blood vessels, potentially leading to organ damage.

It is also being investigated for a progressively fatal immune disorder, hypereosinophilic syndrome, nasal polyps, and eczema.