FDA asks for more data on AstraZeneca diabetes combination drug

The US Food and Drug Administration has issued a complete response letter regarding AstraZeneca’s new drug application for the investigational fixed-dose combination of saxagliptin and dapagliflozin for the treatment of adult patients with type 2 diabetes.

Astra said the letter states that more clinical data are required to support the application, including data from ongoing or completed studies. In addition, the FDA may require information from new studies.

The pharmaceuticals giant said it will work closely with the FDA to determine the appropriate next steps for the NDA and remains committed to the development of the saxagliptin/ dapagliflozin fixed-dose combination.

Nordea Bank said: “This is clear setback for AstraZeneca.”

“Without SaxaDapa, we see AstraZeneca’s diabetes franchise severely weakened (particularly in the US) and increased risk to the company’s ability to sustain the near-term top line as Nexium and Crestor lose exclusivity. Overall, this is substantial blow for AstraZeneca.”

Still, David Morrison, market analyst at SpreadCo, pointed out that the stock has pared opening losses.

“The stock fell close to 1.8% on the open but quickly recovered. It looks as if investors are shrugging off the news despite AZN making a big deal over the drug at the time of Pfizer’s attempted takeover,” he said.

At 0910 BST, AstraZeneca shares were down 0.5% at 4,102p.