REUTERS: The U.S. Food and Drug Administration said on Tuesday it had approved Amgen Inc's osteoporosis treatment for postmenopausal women at high risk of fracture.
Postmenopausal osteoporosis is a chronic condition resulting from progressive bone loss beginning around menopause.
The monthly injection, Evenity, developed jointly with Belgium-based UCB SA, helps reduce the risk of fracture by increasing the formation of new bones and mildly inhibiting the break down of bone minerals. (http://bit.ly/2U4oqZ7)
Evenity comes with a boxed warning, the FDA's harshest, flagging increased risk of heart attack, stroke and cardiovascular-related death.
"It's important to carefully select patients for this therapy, which includes avoiding use in patients who have had a heart attack or stroke within the previous year," said Hylton Joffe, a director at FDA's Center for Drug Evaluation and
William Blair analyst Matt Phipps expects the drug to have slow uptake initially due to the cardiovascular risks, and expects peak sales of US$500 million.
The decision comes months after a panel of experts to the FDA overwhelmingly voted for the drug's approval.
(Reporting by Manas Mishra and Saumya Sibi Joseph in Bengaluru; Editing by Shounak Dasgupta)