GSK preps FDA app after albiglutide beats Januvia in Harmony 8

GlaxoSmithKline ($GSK) says it has now obtained the final piece in the Phase III puzzle needed to win regulatory approval for the diabetes drug albiglutide, a GLP-1 candidate. GSK is partnered on the drug with Human Genome Sciences, now the target of a $2.6 billion hostile offer.

In this latest study GSK investigators say they found that albiglutide compared well with Januvia–a Merck ($MRK) drug which earned $4.9 billion last year. And investigators say that a meta-analysis shows that the drug worked without raising the risk of cardiovascular disease. If regulators approve the drug in 2013, GSK will angle in to a crowded market that includes the injectable Victoza as well as Byetta and Bydureon, which are being acquired by Bristol-Myers Squibb ($BMY) in the Amylin ($AMLN) buyout.

The drug is looking like a definite plus for GSK, but not a blockbuster. Thomson Pharma notes that among analysts the average sales estimate for the drug is $285 million. The Harmony 8 data, coming from the last in a long line of late-stage trials, should help the drug gain traction against Januvia (sitagliptin).

At the 26-week primary endpoint, says GSK, albiglutide "showed clinically and statistically significant reductions in HbA1c from baseline (8.08% for albiglutide and 8.22% for sitagliptin) and superiority versus sitagliptin (reduction of 0.83% vs 0.52%; p<0.0001 for non-inferiority and p=0.0003 for superiority).  At the primary endpoint, weight loss was significantly greater in the albiglutide group than the sitagliptin group (-0.79kg vs -0.19kg; p=0.0281)."

- here's the press release
- here's the Reuters report

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