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GSK closes in on EU approval for triple COPD therapy

CHMP backs its Telegy/Elebrato combination

GlaxoSmithKline (GSK)

GlaxoSmithKline has a lot riding on its new three-drug combination for chronic obstructive pulmonary disease (COPD), so will be celebrating a CHMP recommendation that could see the drug approved before the end of the year.

The EMA's advisory committee gave its blessing for Trelegy/Elebrato (fluticasone furoate, umeclidinium and vilanterol) as a maintenance therapy for COPD patients who do not respond to two-drug therapy with an inhaled corticosteroid (ICS) and a long-acting beta agonist (LABA).

The new product adds long-acting muscarinic receptor antagonist (LAMA) umeclidinium to the ICS/LABA combination, which has proved so successful in GSK's big-selling Advair/Seretide (fluticasone propionate/salmeterol) product, now facing sales declines because of generic competition, and follow-up Breo (vilanterol/fluticasone furoate).

The benefits of Trelegy/Elebrato - delivered using the company's Ellipta dry powder inhaler - are its ability to improve lung function compared to AstraZeneca's ICS/LABA combination Symbicort (budesonide/formoterol) in uncontrolled patient with moderate-to-severe COPD, according to the CHMP.

GSK thinks it has a decent head start with the triple therapy in a market increasingly crowded with LAMA/LABA and LABA/ICS combinations, and has suggested it could dominate the market on the same way Advair did on launch, when monotherapies prevailed in COPD.

As it stands up to a third of patients end up on triple therapy using multiple inhalers, and GSK thinks the advantages of delivering three drugs in one device will be attractive for patients and prescribers.

Analysts have suggested that the drug may find it difficult to gain traction, however, given the pricing pressure on respiratory medicines - particularly in the US - and the availability of cut price generic two-drug combinations.

The three-drug regimen has been developed in collaboration with Innoviva (formerly Theravance) and according to analysts could be a $1bn-2bn product by 2028, failing well short of the $7bn-a-year that Advair brought in at its peak.

The triple has been approved on the back of data from the FULFIL trial, but GSK has a second study - called IMPACT - due to report later this year that will compare the new product with both ICS/LABA and LAMA/LABA combinations. If positive this could accelerate sales growth, according to analysts.

GSK said regulatory applications for the triple have been submitted and are under review in a number of other countries, including the US, Australia and Canada.

The CHMP also delivered more good news to GSK by recommending approval of the company's subcutaneous pen-injector of Benlysta (belimumab), providing a more patient-friendly alternative to the current infusion formulation. Benlysta is used as an add-on treatment for adults with active, autoantibody-positive systemic lupus erythematosus (SLE).

18th September 2017

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