7. Evenity

Amgen
(Amgen)

Active ingredient: romosozumab
Disease: osteoporosis
Peak sales estimate: over $500 million
Approved: April 9, 2019
Companies: Amgen and UCB

The scoop: After a 2017 FDA rejection, Amgen and UCB refiled and won the go-ahead for osteoporosis drug Evenity in a smaller group of postmenopausal women who are at high risk of fracture. Unlike widely used bisphosphonate drugs, which only prevent the loss of bone mass, Evenity is designed to stimulate bone growth to repair damage. In a phase 3 study dubbed Arch, the drug beat Merck & Co.’s Fosamax at reducing the incidence of new fractures and at increasing bone mineral density. But the study also raised a cardiovascular safety problem that led to a boxed warning barring its use in some at-risk patients, even though another phase 3 trial comparing Evenity with placebo didn’t flag the same issue. Despite the smaller patient pool, Jefferies analyst Michael Yee, in an April note, still estimated Evenity could reach over $500 million in peak sales. The new drug competes against Eli Lilly’s blockbuster Forteo—and possibly its generic versions starting from next year—and Radius Health’s Tymlos, both of which boost bone formation. Evenity, which can be given for no more than a year, has been priced on par with Tymlos. — Angus Liu

7. Evenity

Suggested Articles

The data was highly anticipated, especially since the two partners continued testing after the compound missed its endpoints in phase 2 studies.

Removing the IRE1-alpha gene from beta cells in mouse models of Type 1 diabetes restored normal insulin production, scientists found.

Vertex is keeping mum on exact details but, as with the rest of its biopharma peers, is seeing trial disruption due to the COVID-19 pandemic.