Radius Health Files sNDA for TYMLOS® in Men with Osteoporosis
Radius Health filed a Supplemental New Drug Application (sNDA) with the FDA on February 25, 2022, ahead of schedule. This filing is based on positive results from the Phase 3 ATOM study, which demonstrated significant increases in bone mineral density (BMD) in men with osteoporosis. The FDA's review period is expected to last 10 months. The full dataset from the ATOM study will be presented at the AACE Annual Meeting on May 12-14, 2022. This marks a crucial step for Radius in making TYMLOS available for the treatment of osteoporosis in men.
- Filed sNDA for TYMLOS ahead of schedule on February 25, 2022.
- sNDA based on positive data from the ATOM study, which met its primary endpoint for BMD increase.
- Potential expansion of TYMLOS market to include men with osteoporosis, addressing a significant medical need.
- FDA review period spans 10 months, delaying market availability.
- Filed sNDA with the FDA ahead of schedule on Friday, February 25, 2022
- Filing based on the positive ATOM study data previously announced on October 18, 2021
- There is a 10-month FDA review
BOSTON, March 01, 2022 (GLOBE NEWSWIRE) -- Radius Health, Inc. (“Radius” or the “Company”) (NASDAQ: RDUS) provided a business progress and regulatory update.
On February 25, 2022, the Company filed a Supplemental New Drug Application (sNDA) with the Food and Drug Administration (FDA) for TYMLOS (abaloparatide) subcutaneous injection in men with osteoporosis at high risk for fracture.
The sNDA filing will be a 10-month FDA review and is based on data from the Phase 3 ATOM study that was announced on October 18, 2021. The ATOM study met the primary endpoint of change in lumbar spine bone mineral density (BMD) at 12 months compared to placebo as well as secondary endpoints relating to BMD changes in hip and femoral neck.
Bruce Mitlak MD, the Chief Medical Officer of Radius, provided important commentary by emphasizing, “although osteoporosis is known to affect postmenopausal women,
Dr. Mitlak added, “The ATOM study demonstrated abaloparatide resulted in significant increases in BMD at the lumbar spine and hip. The filing of the sNDA is an important step towards making abaloparatide available for men with osteoporosis.”
The Company plans to present the full data set from the ATOM study at the upcoming American Association of Clinical Endocrinology (AACE) Annual Meeting on May 12-14, 2022.
About Radius
Radius is a global biopharmaceutical company focused on addressing unmet medical needs in the areas of bone health, orphan diseases, and oncology. Radius’ lead product, TYMLOS® (abaloparatide) injection, was approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture. The Radius clinical pipeline includes investigational abaloparatide injection for potential use in the treatment of men with osteoporosis; an investigational abaloparatide transdermal system for potential use in the treatment of postmenopausal women with osteoporosis; the investigational drug, elacestrant (RAD1901), for potential use in the treatment of hormone-receptor positive breast cancer out-licensed to Menarini Group; and the investigational drug RAD011, a synthetic cannabidiol oral solution with potential utilization in multiple endocrine, neurological, and metabolic orphan diseases, initially targeting Prader-Willi syndrome, Angelman syndrome, and Infantile Spasms.
About TYMLOS (abaloparatide) injection
TYMLOS (abaloparatide) injection was approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.
About ATOM Phase 3 Study
The ATOM Phase 3 study was a randomized, double-blind, placebo-controlled study to assess efficacy and safety of abaloparatide injection in 228 men with osteoporosis. The primary endpoint was the change in lumbar spine BMD at 12 months compared with placebo.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements.
These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the adverse impact the ongoing COVID-19 pandemic is having and is expected to continue to have on our business, financial condition and results of operations, including our commercial operations and sales, clinical trials, preclinical studies, and employees; quarterly fluctuation in our financial results; our dependence on the success of TYMLOS, and our inability to ensure that TYMLOS will obtain regulatory approval outside the U.S. or be successfully commercialized in any market in which it is approved, including as a result of risk related to coverage, pricing and reimbursement; risks related to competitive products; risks related to our ability to successfully enter into collaboration, partnership, license or similar agreements; risks related to clinical trials, including our reliance on third parties to conduct key portions of our clinical trials and uncertainty that the results of those trials will support our product candidate claims; the risk that adverse side effects will be identified during the development of our product candidates or during commercialization, if approved; risks related to manufacturing, supply and distribution; and the risk of litigation or other challenges regarding our intellectual property rights. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, or SEC, including under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ending December 31, 2021 and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Investor & Media Relations Contact:
Ethan Holdaway
Email: investor-relations@radiuspharm.com
Phone: (617) 583-2017
FAQ
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