London-based drug firm, AstraZeneca got a nail blow after USFDA declined to approve a fixed-dose diabetes drug combination which in-turn has delayed its launch.
In a statement, AstraZeneca said that some of this information could come from completed or ongoing studies, but it did not rule out the possibility of having to carry out additional trials, potentially delaying approval for some time.
The combination of DPP-4 inhibitor saxagliptin - sold by AZ as Onglyza - and SGLT2 inhibitor dapagliflozin (marketed as Farxiga/Forixiga) is considered to be a key component of the company's late-stage diabetes pipeline.
The two drug classes are both growing quickly in the marketplace thanks to clinical data showing improved glucose control compared to older oral antidiabetic drugs (OADs).
Deutsche Bank analyst Richard Parkes said the FDA move probably reflected lack of data on the new formulation rather than safety or efficacy concerns and it seemed likely a launch would simply be delayed by between 12 and 24 months.
Morgan Stanley analysts said a best-case scenario was an 8-10 months' delay but this could extend to a few years if new clinical trials were needed. Last year, during its defense against a $118 billion takeover attempt by Pfizer, AstraZeneca predicted the saxagliptin and dapagliflozin fixed-dose combination could generate peak annual sales of $3 billion, out of total diabetes revenue of $8 billion expected by 2023.
AstraZeneca said the FDA wanted to see more clinical trial data from ongoing or completed studies and it might also require information from new studies.
Individual component drugs in the new mix are already approved and marketed for the treatment of type 2 diabetes, under the brand names Onglyza and Farxiga, and the FDA move is not expected to affect their status, the company added.
Sales of Onglyza reached $391 million in the first half of 2015, with recently launched Farxiga selling $205 million. Onglyza is a type of diabetes medicine known as a DPP-IV inhibitor, similar to Merck's highly successful Januvia.
In a statement, AstraZeneca said it will "work closely with the FDA to determine the appropriate next steps for the [marketing application] and remains committed to the development of the saxagliptin/ dapagliflozin fixed-dose combination"..