A potential new blockbuster diabetes drug will have to sit on the shelf a few months longer as researchers gather up more safety data on the therapy.
AstraZeneca and Bristol-Myers Squibb say that the FDA has informed them that the agency will extend its review of saxagliptin, which will be marketed as Onglyza, for three more months. The new PDUFA date is July 30. If it is approved, the DPP-4 inhibitor is expected to offer Merck's Januvia some stiff competition.
Analysts say the delay makes sense, since saxagliptin is in a study involving patients with kidney damage to rule out potential side effects. Those side effects scuttled Novartis' chances to gain an approval for the DPP-4 inhibitor Galvus.
"Because of the pre-clinical similarities between Onglyza and Galvus we believe the FDA will want to see this data, even if only interim data, before coming to a final decision, and as such we stick to our mid-2010 launch estimates," said WestLB analyst Simon Mather.
- check out the story from Reuters