GlaxoSmithKline brings forward COPD application in US by over a year

GlaxoSmithKline has, after discussions with the US regulator, accelerated the new drug application for its daily closed triple therapy for chronic obstructive pulmonary disease (COPD).

GSK and its partner in the drug, Innoviva, now expect to make the US regulatory submission before the end of 2016, rather than in the first half of 2018, as previously expected.

Enclosed in a canister, the once-daily treatment employs three active drug molecules delivered via GSK's Ellipta dry powder inhaler: inhaled cortico-steroid, fluticasone furoate (FF); umeclidinium (UMEC), an anti-cholinergic; and vilanterol (VI), a long-acting beta2-adrenergic agonist.

The new drug application to the US Food and Drug Administration (FDA) will be made using data now in hand from the closed triple combination therapy development programme, as well as data from individual studies with FF, UMEC and VI either alone or in combination.

GSK and Innoviva's current clinical programme in patients with COPD comprises two studies comparing the triple therapy against rival treatments, one of which is expected to read out later in 2016 to support its EU filing and the other in 2017.

"The announcement is good news for the company," said broker Shore Capital, as Glaxo's portfolio of new respiratory drugs eases the transition away from Advair.

However, ShoreCap analyst Tara Raveendran said the company's focus in the near term is likely to remain on Anoro/Incruse/Breo and the novel biologic, anti-IL5 mAb Nucala.

She also noted that GSK and Regulus Therapeutics have also announced that they are to expand their clinical trial collaboration that focuses on a combination treatment as a potential single-visit cure for patients with chronic HCV infection.

The study is planned to start in 4Q16 and will take place outside of the US, with interim results in 2H17. The deal will involve an equal cost sharing arrangement between the two parties, but there are no further obligations or commitments beyond the expanded clinical collaboration agreement.