Actionable news
0
All posts from Actionable news
Actionable news in AZN: ASTRAZENECA PLC,

AstraZeneca diabetes drug combination faces delay after FDA rebuff

* U.S. FDA issues complete response letter for saxa/dapa

* Setback may mean delay of 1-2 years, analysts believe

* AstraZeneca predicted $3 bln sales for combination (Adds analyst comments on likely length of delay)

LONDON, Oct 16 (Reuters) - U.S. health regulators declined to approve a fixed-dose diabetes drug combination from AstraZeneca, delaying its launch and dealing a blow to an important plank of the drugmaker's business.

AstraZeneca said on Friday it had received a so-called complete response letter from the Food and Drug Administration (FDA) stating that more clinical data were required before it could approve the combination of saxagliptin and dapagliflozin.

Such letters typically outline concerns and conditions that must be addressed to gain U.S...


More