EU breathes hope into GlaxoSmithKline's latest respiratory contender

A European Medicines Agency committee is recommending approval for another COPD treatment from GlaxoSmithKline ($GSK), setting the stage for a likely nod in the coming months as the drugmaker looks to bolster its respiratory franchise.

GSK's latest entrant is Incruse, which delivers the long-acting muscarinic antagonist (LAMA) umeclidinium through the Ellipta inhaler. In its review, the EMA's Committee for Medicinal Products for Human Use smiled on Incruse's risk-benefit profile, applauding its effect on lung function while noting that its cardiovascular and cerebrovascular dangers merit post-approval attention. Now it's up to GSK to wait on the European Commission, which generally follows the recommendations of the CHMP, and on the FDA, which has been reviewing Incruse since April, the company said.

The once-daily treatment uses one half of the LAMA/long-acting beta2 agonist cocktail in the recently launched Anoro, reflecting GSK's all-encompassing approach to COPD as it works to build up a multibillion-dollar franchise to replace the $8 billion in Advair revenue it will presumably lose once generics come for that drug.

And GSK, thanks in large part to its 12-year partnership with Theravance ($THRX), is so far succeeding. Last year, the U.K. drugmaker won FDA approvals for Anoro and Breo, two COPD drugs expected to bring in more than $2.5 billion at their peaks. Incruse, if it can win FDA approval, would only augment GSK's status at the top of the respiratory space. The COPD market is expected to reach $14 billion by 2018 due to mounting health problems around the world.

Leading the pipeline for GSK and Theravance is GSK961081, a mid-stage bifunctional muscarinic antagonist-beta agonist (MABA) that has shown promise in COPD and patients with severe asthma.

Separately, CHMP recommended a new formulation of Novartis' ($NVS) LABA/LAMA Ulunar Breezhaler, a combo COPD treatment from Teva ($TEVA), a fixed-dose diabetes cocktail from Johnson & Johnson ($JNJ) and a pain killer from Pfizer ($PFE)

- read the EMA opinion (PDF)
- here's GSK's statement

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