The FDA just approved saxagliptin, a diabetes medicine that will be co-marketed by Bristol-Myers Squibb and AstraZeneca. The drug, which will be sold under the brand name Onglyza, is in a relatively new class, called DPP-4 inhibitors, that can be taken along with older diabetes drugs. Until now, Merck’s Januvia has been the only drug in the class on the market in this country. But in late 2006, when Januvia was approved by the FDA, you wouldn’t have guessed that Merck would have the market to itself for so long. That it has is a sign of the tough safety scrutiny the FDA has given to many new drugs in recent years. The 2006 WSJ story on Januvia’s approval noted that Galvus, a DPP-4 drug from Novartis, was also awaiting approval. But that

drug was delayed, then delayed again, over safety concerns based on animal studies — and Novartis finally walked away from getting it approved here (it is approved in Europe). Takeda submitted its own DPP-4 drug, alogliptin, back in 2007, but that drug also has yet to be approved by FDA — and a statement from Takeda in March of this year suggested that the company may need to gather more data for FDA because of broad concerns about cardiovascular risks for all diabetes drugs. All these delays, of course, have been just fine for Merck. In the first quarter of this year, the company’s sales of Januvia were over $400 million . Photo: Bloomberg News

Go here to read the rest:
Saxagliptin Approval: Finally, Competition for Merck’s Januvia