GlaxoSmithKline will have to wait a few more months before it hears the FDA's final decision on albiglutide, a new diabetes drug that is aiming to compete against a growing host of rivals.
Glaxo ($GSK) says that the FDA asked for more time to review the information the pharma company had submitted in response to the agency's queries and pushed back the deadline to April 15, 2014. Glaxo also has an application pending with the EMA.
The delay isn't a game changer for Glaxo, but it puts off a potential approval for a drug company anxious to see some real progress on the regulatory front. It also allows competing drugs more time to get established before Glaxo shows up.
Novo Nordisk's ($NVO) Victoza, Sanofi's ($SNY) Lyxumia, and Byetta and Bydureon from the Bristol-Myers Squibb ($BMY)/AstraZeneca ($AZN) team are already angling for market share in the same GLP-1 class. And Eli Lilly's ($LLY) dulaglutide has garnered considerable enthusiasm from analysts who have inspected the late-stage data. Dulaglutide emerged from the American Diabetes Association in June as the clear frontrunner, especially after albiglutide was bested by Takeda's Actos in a head-to-head study. Patients taking albiglutide also faced more gastrointestinal side effects, which is also likely to limit its market potential.
- here's the press release
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