FDA asks for more clinical data on AstraZeneca's filing for Onglyza, Farxiga combination

AstraZeneca announced Friday that the FDA issued a complete response letter regarding a filing seeking approval of a fixed-dose combination of the DPP-4 inhibitor Onglyza (saxagliptin) and the SGLT-2 inhibitor Farxiga (dapagliflozin) for the treatment of adults with type 2 diabetes.

The agency said that "more clinical data are required to support the application," with the company noting that this may include information from ongoing trials as well as new studies. AstraZeneca indicated that it "will work closely with the FDA to determine the appropriate next steps," adding that it "remains committed to the development" of the fixed-dose combination product.

AstraZeneca noted that the FDA's decision does not affect ongoing interactions with other health authorities regarding filings for the therapy. The drugmaker said that "based on the information available, the [complete response letter] is not expected to affect individual components" of Onglyza and Farxiga.

"This is clearly bad news," commented Bloomberg Intelligence analyst Sam Fazeli, noting "it's not clear how long they will have to wait." The combination therapy would have competed with Boehringer Ingelheim and Eli Lilly's Glyxambi (empagliflozin/linagliptin), which was approved by the FDA as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes in February. Fazeli said Glyxambi now has "a clear run in the US."

A previous forecast from Kepler Cheuvreux analyst Fabian Wenner estimated that AstraZeneca's combination therapy could generate at least $850 million in sales by 2020, while the company has predicted peak annual revenue of $3 billion by 2023. Onglyza, which was approved by the FDA in 2009, generated sales of $391 million in the first half of 2015, with Farxiga, which was cleared by the agency last year, amassing six-month revenue of $205 million.

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