This article is more than 5 years old. Information may no longer be current.

FDA accepts new drug application for osteoporosis medication

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

The FDA recently accepted and filed a new drug application for abaloparatide-SC, according to a release from Radius Health.

“The FDA’s acceptance for filing of our abaloparatide-SC [new drug application] is a major milestone for Radius and we look forward to continuing the work with the FDA as they review our application,” Robert E. Ward, president and CEO of Radius Health, said in the release. “Given the high unmet medical need in osteoporosis, we believe that abaloparatide-SC, if approved, has the potential to become a promising new treatment option for the approximately 10 million postmenopausal women with osteoporosis, many of whom remain untreated.”

The application is supported by results from the 18-month phase 3 ACTIVE trial that included 2,463 postmenopausal women with osteoporosis and the first 6 months of the ACTIVExtend trial that included 1,139 of the ACTIVE participants. Both trials have met the primary and secondary endpoints for a new drug application including a reduction of vertebral, nonvertebral, clinical and major osteoporotic fractures. Abaloparatide appears to be safe and well tolerated in postmenopausal women with osteoporosis at a dose of 80 µ daily.