Bristol-Myers, AstraZeneca win turnabout at NICE for Forxiga

Bristol-Myers Squibb ($BMY) and AstraZeneca ($AZN) persuaded the U.K.'s cost-effectiveness agency to make an about-face on their new diabetes drug Forxiga. The agency, which initially nixed the treatment, now recommends it in certain circumstances. It's a key victory for the new drug, which is approved in Europe but not yet cleared by the FDA.

The National Institute for Health and Care Excellence (NICE) says new data analyses and a new review of the economic model submitted by the companies helped change its mind. The agency's latest draft guidance now recommends Forxiga in combination with the common blood-sugar-moderating drug metformin, and in combination with insulin. It's not recommended as part of a triple-drug regimen.

"We are pleased to recommend dapagliflozin for some people with type 2 diabetes," NICE health technology evaluation chief Carole Longson said in a statement. "It is a serious problem in the U.K., and dapagliflozin provides another treatment option for some people with this condition."

Both Bristol-Myers and AstraZeneca have bet on diabetes in a big way. They amped up their diabetes-focused partnership with the purchase of Amylin Pharmaceuticals and its drugs Byetta and Bydureon, and now aim to offer a suite of treatments for the disease in mature and emerging markets. Forxiga is the fourth new drug to emerge from that partnership, and though it's not expected to dominate the diabetes market, it has been tagged with peak sales of $700 million.

Forxiga is a first-in-class drug that works by pushing blood glucose out of the body via the kidneys. It's designed to complement the metformin-plus-insulin treatment combination commonly used by type 2 diabetics. The fact that NICE only recommends it in combination with either metformin or insulin, not both, may limit its initial use, but the companies may be able to persuade NICE on the triple-therapy approach at a later date. NICE, incidentally, recently changed its proper name, substituting the word "care" for "clinical" in its previous incarnation.

Meanwhile, the companies need to persuade the FDA that Forxiga should be part of the diabetes array in the U.S., too. The U.S. agency declined to approve Forxiga last year, worried about cardiovascular safety. The two companies say they're planning to go back to the agency with fresh data next year.

- see the NICE release

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