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FDA queries safety of GSK's Anoro for COPD

Adviser questions the drug's cardiovascular profile

GlaxoSmithKline (GSK) logoGlaxoSmithKline faces an FDA advisory committee meeting tomorrow on its chronic obstructive pulmonary disease (COPD) candidate Anoro, and the drug's safety is likely to be a focal point for discussions.

A briefing document published by the FDA ahead of the meeting suggest that the agency's reviewer is fairly convinced by the efficacy of Anoro - which combines long-acting beta agonist (LABA) vilanterol with long-acting muscarinic antagonist (LAMA) umeclidinium bromide - but has some reservations about the drug's cardiovascular safety.

Anoro represents a "new type of combination product comprised of a novel LAMA and LABA", says the document, which points out that most experience to date has been with short-acting versions of these drug classes. At the moment there are no approved LAMA/LABA combinations in the US.

Data from the four main clinical trials of Anoro provide evidence of efficacy, and while safety data was largely in line with LAMA and LABA drug classes there was "a small imbalance" in non-fatal heart attack rates and some discrepancies in withdrawals from the studies due to abnormalities on electrocardiogram (ECG) or Holter monitoring.

"Whether these imbalances and discrepancies constitute a safety signal when taken in the context of the complete development programme will be a topic for further discussion," says the reviewer.

Anoro is one of a pair of new combination COPD drugs being developed by GSK and partner Theravance as successors to the pharma company's massive-selling Advair/Seretide (fluticasone and salmeterol) product, which garnered sales of $7.6bn last year but is starting to lose patent protection in some markets.

The other - Breo/Relvar (fluticasone furoate plus vilanterol) - was approved by the FDA in May and is under regulatory review in Europe. Both combination therapies are delivered using a new inhaler device called Ellipta which - like the Diskus inhaler used in Advair - boost patient compliance and efficacy while also making it harder for generics companies to enter the market after patents expire.

Analysts have predicted that Anoro and Breo could bring in sales of around $4bn a year at peak, going most of the way towards replacing Advair sales when the product finally succumbs to generic competition.

GSK will find the COPD market increasing competitive, however, with a panoply of other new COPD combinations coming through the pipeline, including Boehringer Ingelheim/Pfizer's olodaterol/tiotropium, Novartis' QVA149 (glycopyrronium bromide/indacaterol maleate) and Forest Labs/Almirall's aclidinium bromide/formoterol candidate.

A final decision from the FDA on Anoro is expected by December 18.

9th September 2013

From: Research, Sales

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