Evenity (Romosozumab): Legal and Patent Challenges
At a glance
- FDA approval / April 9, 2019, BLA 761062 [1][2]
- Label effective / July 16, 2026 [2]
- U.S. indication / Postmenopausal women at high risk for fracture [2]
- Treatment limit / 12 monthly doses [2]
- Boxed warning / Myocardial infarction, stroke and cardiovascular death [2]
- EU restriction / Must not be given after a heart attack or stroke [3]
What is documented about approval and indication?
The FDA approved Evenity under BLA 761062 on April 9, 2019; the label in use is effective July 16, 2026 [1][2]. The indication is osteoporosis in postmenopausal women at high risk for fracture: a history of osteoporotic fracture, multiple risk factors for fracture, or failure of or intolerance to other available osteoporosis therapy [2]. It is not labeled for men or premenopausal women, and the pregnancy section says it is not indicated for women of reproductive potential [2]. Treatment is limited to 12 monthly doses; the label states the anabolic effect wanes after that, and bone mineral density returns to about baseline within 12 months after stopping without follow-on anti-resorptive therapy [2].What does the boxed warning say?
The boxed warning is titled WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE AND CARDIOVASCULAR DEATH [2]. It says Evenity may increase the risk of myocardial infarction, stroke and cardiovascular death, and should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year [2]. It says to weigh benefits against risks in patients with other cardiovascular risk factors and to discontinue Evenity if a myocardial infarction or stroke occurs during therapy [2]. In the 12-month alendronate-controlled trial, positively adjudicated major adverse cardiac events were 2.0% (41 of 2,040) with Evenity versus 1.1% (22 of 2,014) with alendronate, hazard ratio 1.87 (95% CI 1.11 to 3.14); in the placebo-controlled trial they were 0.8% (30) versus 0.8% (29), hazard ratio 1.03 (95% CI 0.62 to 1.72) [2]. A recent MI or stroke is a boxed-warning restriction, not listed under Contraindications [2].How does the EU authorization differ?
The EMA says Evenity is authorized for women after menopause with severe osteoporosis (low bone density and previous fracture) and a high risk of further fractures [3]. It says the medicine must not be given to patients who have already had a heart attack or stroke, and must not be used in patients with hypocalcemia [3]. The EMA says EU treatment is started and supervised by a specialist with experience treating osteoporosis, and the company will provide educational materials for doctors and an alert card for patients [3]. The U.S. label instead says Evenity should not be initiated within one year of a myocardial infarction or stroke, and to weigh benefits and risks in patients with other cardiovascular risk factors [2].Frequently asked questions
When was Evenity approved by the FDA?
Evenity (romosozumab-aqqg) was approved under BLA 761062 on April 9, 2019; the label in use is effective July 16, 2026 [1][2].
Is Evenity approved for men?
No. The FDA label covers postmenopausal women at high risk for fracture, and says the drug is not indicated for women of reproductive potential [2]. The EMA page describes use in women after menopause [3].
How long is Evenity treatment?
The label limits treatment to 12 monthly doses. It states the anabolic effect wanes after 12 doses and that bone mineral density returns to about baseline within 12 months after stopping without follow-on anti-resorptive therapy [2].
Does the EU authorization differ from the U.S. label?
Yes. The EMA page says Evenity must not be given to patients who have already had a heart attack or stroke [3]. The U.S. label says it should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year [2].
References
- U.S. Food and Drug Administration. U.S. Food and Drug Administration
- U.S. National Library of Medicine, DailyMed. Evenity (romosozumab-aqqg) injection prescribing information. Evenity (romosozumab-aqqg) injection label
- Evenity | European Medicines Agency (EMA). Evenity | European Medicines Agency (EMA)
- Approved Drug Products with Therapeutic Equivalence Evaluations | Orange Book | FDA. Approved Drug Products with Therapeutic Equivalence Evaluations | Orange Book | FDA