Jan 8 U.S. health regulators on Wednesday
approved an AstraZeneca drug from a new class of
medicines to treat type 2 diabetes after previously rejecting it
over safety concerns.
The Food and Drug Administration nod had been expected this
time around after an outside advisory panel of experts in
December voted by a wide margin to recommend its approval,
saying the benefits of the drug, dapagliflozin, outweighed its
safety risks. It will be sold in the United States under the
brand name Farxiga.
The medicine was co-developed by Bristol-Myers Squibb Co
and AstraZeneca, but Astra late last year bought out
Bristol's stake in their diabetes joint venture for more than $4
billion, including upfront and sales-related milestone payments.