The U.S. Food and Drug Administration last week approved Amgen Inc’s bone-building Evenity for postmenopausal women who are at high risk of fracture but required the label to have a boxed warning, the FDA’s strictest, flagging increased risk of heart attack, stroke and cardiovascular-related death.
U.S: Amgen Inc on Monday set the U.S. list price for its new Evenity osteoporosis drug at $1,825 a month, or $21,900 for a full 12-month course of injections.
The U.S. Food and Drug Administration last week approved bone-building Evenity for postmenopausal women who are at high risk of fracture but required the label to have a boxed warning, the FDA’s strictest, flagging increased risk of heart attack, stroke and cardiovascular-related death.
Since the drug’s target population of older women has an underlying risk for such cardiovascular problems, Wall Street analysts have pulled back on sales expectations for Evenity, which was developed jointly with Belgium-based UCB SA.
Analysts, on average, project Amgen’s Evenity revenue at $274 million a year by 2024, according to IBES data from Refinitiv.
Sales of Amgen’s older osteoporosis drug, Prolia, are forecast to reach $3.3 billion by 2024. Prolia does not build bone as Evenity does. It is designed to block a protein that activates bone-destroying cells called osteoclasts.
Evenity, part of a new class of drugs known as sclerostin inhibitors, was studied in large clinical trials for one year, and the FDA said its use should be limited to one year.
“We priced this product so that it is clearly a better value than existing agents that build bone,” Murdo Gordon, executive vice president of global commercial operations at Amgen, told Reuters in a phone interview.
Since rival bone-building drugs, Tymlos, sold by Radius Health Inc, and Eli Lilly and Co’s Forteo have longer courses of therapy – 18 months to two years – Amgen calculates that Evenity’s price is 34 per cent to 74 per cent below those competitors.
Tymlos and Forteo are both parathyroid hormone drugs.
Evenity is designed to reduce the risk of fracture by increasing bone mass and mildly inhibiting the break down of bone minerals. It is administered by physicians with two 105 milligram injections every month for a year.
“This is a largely under-diagnosed and under-treated disease partly because it is not a symptomatic disease,” Amgen’s Gordon said. “There have been very limited treatment options for women who have had a fracture.”