Amgen’s romosozumab-aqqg therapy (Evenity) for osteoporosis in postmenopausal women is now available for shipment to wholesalers in the United States.

Approved by the FDA on April 9, 2019, the treatment is indicated for osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.

"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, in a prepared statement. "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."

Osteoporosis is a serious, chronic condition with no cure. According to the World Health Organization, the condition is a major public health crisis, affecting millions of people worldwide and about 10 million Americans in the United States. 

Romosozumab-aqqg is a bone-building humanized monoclonal antibody that is designed to work by inhibiting the activity of sclerostin. Inhibiting the activity of sclerostin simultaneously results in increased bone formation and to a lesser extent decreased bone resorption, according to Amgen.

The FDA’s approval of romosozumab-aqqg helps address an unmet need by providing another option for postmenopausal women at high risk for fracture who need to build bone rapidly within 12 months and to reduce the risk of a first or subsequent fracture. A full course of Amgen’s therapy is 12 monthly doses administered by a health care provider.

Amgen’s romosozumab-aqqg has a Boxed Warning in its product label, which advises that this drug may increase the risk of heart attack, stroke and cardiovascular death. The most common adverse reactions (≥ 5 percent) reported with this drug were arthralgia (joint pain) and headache.

Each year, osteoporosis-related fractures account for 432,000 hospital admissions and 180,000 nursing home admissions, according to Amgen. Given the aging population in the U.S., annual direct costs from osteoporosis are expected to reach approximately $25.3 billion by 2025.

According to Amgen, the company is committed to supporting the osteoporosis community and to helping appropriate patients with affordable access to romosozumab-aqqg. The Amgen Assist® support program can help patients and physician offices navigate insurance coverage and identify access resources for patients. The program can also refer patients as a courtesy to other potential resources, such as Amgen Safety Net Foundation, a nonprofit patient assistance program sponsored by the company that can provide romosozumab-aqqg at no cost to qualifying patients who have a financial need and are uninsured or whose insurance plan excludes coverage for this drug.

Amgen will make Evenity available at a U.S. list price of $1,825 per dose, or $21,900 for a full course of treatment (12 monthly doses).
 
New Osteoporosis Therapy for Postmenopausal Women Granted FDA Approval

Reference

EVENITY™ (romosozumab-aqqg) Now Available In The United States For The Treatment Of Osteoporosis In Postmenopausal Women At High Risk For Fracture [news release]. Thousand Oaks, CA; April 15, 2019: Amgen. https://prnmedia.prnewswire.com/news-releases/evenity-romosozumab-aqqg-now-available-in-the-united-states-for-the-treatment-of-osteoporosis-in-postmenopausal-women-at-high-risk-for-fracture-300832295.html. Accessed April 16, 2019.