- Amgen on Tuesday won Food and Drug Administration approval for its osteoporosis treatment Evenity in postmenopausal women at high risk for fracture, two years after the regulator had turned back the biotech and partner UCB's first attempt to secure an OK.
- Unlike some other commonly used drugs for the bone-weakening condition, Evenity works by increasing bone formation as well as reducing bone loss. The drug joins Radius Health's Tymlos and Eli Lilly's Forteo, which are both anabolic agents as well.
- Evenity will carry a boxed warning on its label cautioning of increased risk of cardiovascular events like heart attack or stroke. The FDA is also requiring Amgen to do post-marketing safety monitoring, including a five-year observational feasibility study and — potentially — a comparative safety trial as well.
The market for osteoporosis therapies is vast; the condition affects 10 million people in the U.S. alone.
But Amgen and UCB will have to navigate safety concerns as they position Evenity (romosozumab-aqqg) to compete with Forteo (teriparatide) and Tymlos (abaloparatide).
Doctors will need to weigh the medicine's benefits against cardiovascular risks observed in one study testing Evenity against Fosamax (alendronate), the FDA said. Evenity's label notes it shouldn't be used in patients who have had a heart attack or stroke in the last year.
"It's important to carefully select patients for this therapy," said Hylton Joffe, director of the Center for Drug Evaluation and Research's division that oversees bone products, in an FDA statement released Tuesday.
Even with the boxed warning, Evenity sales may top $500 million worldwide, Jefferies analyst Michael Yee wrote in a note to investors. Yee cited Forteo, which also carries a boxed warning but still posted sales topping $1.5 billion last year.
The FDA approved Evenity for women who have a history of fractures or multiple risk factors for bone breaks, as well as those who either can't tolerate or haven't gotten the needed benefits from other treatments. The medicine, a monoclonal antibody, works by blocking the effects of a protein known as sclerostin, thereby promoting formation of new bone.
Amgen and UCB are touting the therapy's "unique dual effect," allowing it to both build bone mineral density and reduce the bone loss that can lead to fractures.
Most osteoporosis drugs, outside of Forteo and Tymlos, work by reducing bone loss, also known as resorption.
Amgen didn't disclose the price for Evenity, which is administered in 12 monthly doses. SVB Leerink analyst Geoffrey Porges estimated that it will be close to Forteo's $40,000 price tag, or possibly more.
Evenity will probably end up being a late-line therapy, Porges said. Even so, the treatment has the potential for $700 million in peak sales, he noted.