The NWHN’s Statement in Response to FDA Approving Evenity

Contact: Evita Almassi, [email protected] or (202) 682-6240

The following statement can be attributed to Cynthia A. Pearson, Executive Director of the National Women’s Health Network.

Washington D.C. - Yesterday, the US Food and Drug Administration approved a new treatment romosozumab, brand name Evenity, from drugmakers Amgen and UCB for osteoporosis in postmenopausal women who are at high risk of bone fractures.

In two pre-approval studies, women experienced a modest improvement in their absolute risk of spinal fracture (1.3%-4%) using Evenity compared to placebo or alendronate (a common osteoporosis drug). But an increase in major cardiovascular events found in one study raised concerns about the drug’s safety. The FDA initially rejected Evenity in 2017 over these heart safety red flags. Now, the FDA is requiring Amgen to conduct a post-marketing study of cardiovascular risks rather than making additional studies a condition of approval. Unfortunately, such required post-approval studies are not always completed in a timely fashion, if at all.

Evenity will have a black box warning stating these risks and cautioning that the treatment should not be used in patients who have had a heart attack or stroke within the previous year.

In 2018 alone, Amgen made $2 billion on their current osteoporosis drug, denosumab (brand name Prolia), which is set to lose its patent exclusivity in a few years. Amgen is counting on Evenity to boost its profits when that happens. But it’s unclear whether Evenity provides either a long-term benefit over other existing osteoporosis drugs, including Prolia—or even a benefit equal to its risks. Women may be better off taking a cheaper generic version of an existing drug than gambling on Evenity.

“This is Big Pharma looking out for their interests, not the interests of women,” said Cindy Pearson, Executive Director of the National Women’s Health Network. “And the FDA is letting them get away with turning their homework in late, or not at all.”

With so many unknowns surrounding Evenity, the NWHN advises women to talk with their provider about other less risky and cheaper treatments, and consider forgoing the heart health minefield that accompanies Evenity.

The National Women’s Health Network is supported by our members and by choice we do not accept financial support from drug companies or medical device manufacturers. We bring the voices, concerns, and needs of women consumers to policy and regulatory tables.

Cindy Pearson was the NWHN’s Executive Director from 1996 to 2021. One of the nation's leading advocates for women's health, Cindy often testified before Congress,  NIH and the FDA and was frequently featured in the news as a consumer expert on women’s health issues. When she retired, Cindy received a Congressional Resolution in honor of her outstanding contributions to the health of women and girls.

Read more from Cindy Pearson.