Amgen (AMGN) set a list price of $1,825 per month for its Evenity osteoporosis drug. The Food and Drug Administration approved the drug last week, but mandated a "black box" warning about an increased risk of heart attack and stroke.
EVENITY TO COST $1,825 PER DOSE: Amgen on Monday announced that Evenity, its new osteoporosis drug, is now available for shipment to wholesalers in the U.S. Amgen said it will make Evenity available at a U.S. list price of $1,825 per dose, or $21,900 for a full course of treatment of 12 monthly doses. In a statement, Amgen said "This list price for a full course of therapy of Evenity is 34%-74% lower than currently available anabolic agents over their full course of therapy." It added that the price of Evenity is in line with Amgen's "focus on innovation and commitment to responsible pricing for patients in the U.S. and takes into consideration the physical and financial impact osteoporosis-related fractures can have on postmenopausal women and their families and caregivers." Evenity helps reduce the risk of fracture by increasing bone formation and inhibiting break down of bone minerals.
"Osteoporosis is a silent disease that can lead to devastating consequences. Unfortunately, only 20% of women who have experienced a fracture receive any type of osteoporosis treatment post-fracture," said Murdo Gordon, executive vice president of global commercial operations at Amgen. "This is unacceptable for the millions of women who have suffered from an osteoporosis-related fracture. We need to urgently make postmenopausal osteoporosis a women's health priority."
WHAT'S NOTABLE: The U.S. Food and Drug Administration last week approved Evenity for postmenopausal women who are at high risk of fracture, but required the label to have a boxed warning, citing an increased risk of heart attack, stroke and cardiovascular death.
Evenity, part of a new class of drugs known as sclerostin inhibitors, is administered as an under-the-skin injection and was studied in large clinical trials for one year. The FDA, which approved Evenity on the basis of two Phase 3 clinical trials, has said its use should be limited to one year.
Amgen and partner UCB received a complete response letter for the drug from the FDA in 2017, requesting data from an additional study to be included in their marketing application.
Rival treatments Tymlos, which is sold by Radius Health (RDUS), and Forteo, sold by Eli Lilly (LLY), have longer courses of therapy, ranging from 18 months to two years.
RECENT ANALYST COMMENTARY: Jefferies analyst Michael Yee said last week that despite the inclusion of a boxed warning highlighting the potential increased cardiovascular risk, Evenity is an incremental $500M-plus drug for Amgen. The analyst pointed out that Eli Lilly's Forteo did $1.5B despite a warning label for bone cancer.
PRICE ACTION: In morning trading, shares of Amgen are fractionally higher to $192.35.
