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GSK brings forward triple COPD therapy filing in US

Intends to file the three-drug respiratory therapy by the end of 2016
GlaxoSmithKline

GlaxoSmithKline has said it intends to file a new three-drug combination therapy 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 now says it will submit it before the end of 2016, at around the same time as its European application.

The once-daily therapy developed by GSK and Innoviva (formerly Theravance) comprises corticosteroid 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.

After discussions with the FDA, GSK has determined that it can base its US marketing application on data already in hand, either on the triple therapy or the three constituent drugs. All three are already on the market either as monotherapies or dual combinations.

The triple therapy is viewed as an opportunity for GSK to recapture its leading position in the COPD market, which has been dented by pricing pressure and competition to blockbuster product Seretide/Advair (fluticasone propionate/salmeterol).

Generic versions of Seretide/Advair are already on the market in Europe and could be on the US market before the end of 2016.

The company suffered declining respiratory sales through 2015 - although its performance improved in the first quarter of this year thanks to gathering momentum for two-drug combinations Relvar/Breo (vilanterol/fluticasone furoate) and Anoro (vilanterol/umeclidinium bromide).

GSK is jostling for market share with other two-drug combinations, however, including Novartis' Ultibro (glycopyrronium/indacaterol), AstraZeneca's Duaklir (aclidinium bromide/formoterol fumarate) and Boehringer Ingelheim's Spiolto (tiotropium/olodaterol).

Analysts have predicted that the new dual therapy entrants are unlikely to reach the $7bn-a-year in sales enjoyed by Seretide at its peak, and are much more likely to be in the $1bn-$2bn range.

GSK will be hoping its three-drug therapy will do somewhat better, with an opportunity to differentiate itself from the pack if the large-scale FULFIL trial - due to report data next year - is positive.

Article by
Phil Taylor

2nd June 2016

From: Regulatory

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