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GSK files first application for triple COPD therapy

Submits combo in the US one year early to coincide with EU marketing application

GlaxoSmithKline has submitted its three-in-one treatment for chronic obstructive pulmonary disease (COPD) in the US, more than a year earlier than planned.

GSK had previously suggested it would file the three-drug therapy in the US in the first half of 2018, but has now brought forward that date to coincide with a marketing application in the EU, due in the next few weeks.

The therapy is a single device delivering inhaled corticosteroid (ICS) fluticasone furoate, long-acting beta agonist (LABA) vilanterol and long-acting muscarinic antagonist (LAMA) umeclidinium - covering the three most widely-used inhaled drug classes in COPD.

All three are already on the market either as monotherapies or dual combinations, but GSK believes a triple therapy has the potential to outperform rivals and take a lead in the marketplace. It already has data in hand from the FULFIL trial showing it is more effective than AstraZeneca's Symbicort (formoterol and budesonide).

The combination is a key element in GSK's efforts to return to growth in its respiratory business, which has been hit by pricing pressure in the US and stiffer competition to blockbuster product Seretide/Advair (fluticasone propionate/salmeterol), both from generics and other two-drug combinations.

A generic version of Advair is currently under review with the FDA and looks set to roll out in the US after March next year, and GSK has already tried to protect its franchise with the launch of new two-drug combinations such as Relvar/Breo (vilanterol/fluticasone furoate) and Anoro (vilanterol/umeclidinium bromide).

GSK's head of respiratory R&D Dave Allen said that for around a third of patients with advanced COPD, "multiple therapies such as ICS/LAMA/LABA combinations are often required and are typically delivered via two or more inhalers with potentially differing dose regimens".

"This first regulatory submission of our closed triple therapy brings us a step closer to providing a once-daily treatment in a single Ellipta inhaler as an alternative option for those patients who require multiple therapies," he added.

The three-drug regimen has been developed in collaboration with Innoviva (formerly Theravance) and according to analysts could be a $1bn-2bn product. While that will not come close to the $7bn a year achieved by Seretide at its peak, they suggest GSK's portfolio of new drugs will help it remain a major player in the sector.

One possible fly in the ointment is a clinical trial reported last year which found that removing the steroid component from a triple therapy had no impact on the frequency of exacerbations among moderate-to-severe COPD patients, which could limit interest in triple therapies.

Article by
Phil Taylor

21st November 2016

From: Regulatory



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