AMA Publishes Positive Phase 3 Data for Abaloparatide in Postmenopausal Women with Osteoporosis
The Company is Radius Health (RDUS) and the new expected to be soon approved drug, abaloparatide, is an investigational therapy for the potential treatment of women with postmenopausal osteoporosis who are at an increased risk for a fracture. It is a novel synthetic peptide that engages the parathyroid hormone receptor (PTH1 receptor) and was selected for clinical development based on its favorable bone building activity.
Abaloparatide has completed Phase 3 development for potential use as a daily self-administered injection (abaloparatide-SC). In the fourth quarter of 2015, Radius’ Marketing Authorisation Application (MAA) was validated and is currently undergoing regulatory review by the European Medicines Agency (EMA). Radius submitted a New Drug Application (NDA) for abaloparatide-SC to the FDA at the end of the first quarter of 2016, which has been accepted for filing with a PDUFA date of March 30, 2017. Radius also is developing abaloparatide-transdermal (abaloparatide-TD) based on 3M’s patented Microstructured Transdermal System technology for potential use as a treatment for osteoporosis.
Radius Health announced that positive results from the Phase 3 ACTIVE trial were published in the Journal of the American Medical Association (JAMA). The trial enrolled 2,463 patients to evaluate the safety and efficacy of investigational drug abaloparatide for the treatment of postmenopausal women with osteoporosis.
The results showed that patients treated with daily abaloparatide for 18 months had a significantly greater reduction in the incidence of new vertebral fractures and nonvertebral fractures compared to placebo.
Dr. Paul Miller, Medical Director at the Colorado Center for Bone Research and lead author of the paper stated, “The landmark ACTIVE trial results are important and further validate abaloparatide’s potential to consistently, substantially and rapidly reduce both new vertebral and nonvertebral fractures in postmenopausal women with osteoporosis. Approximately two million osteoporotic fractures occur annually in the U.S., which create physical and psychological burdens for affected women by diminishing their independence and quality of life. There is a great unmet medical need for therapies which could provide more consistent potent and early benefits to patients.”
Dr. Lorraine A. Fitzpatrick, Chief Medical Officer of Radius said, “We are honored to have these findings published in JAMA, and are encouraged by the totality of data collected to date which demonstrate that abaloparatide, if approved, could have a significant impact in improving outcomes for women with postmenopausal osteoporosis. We look forward to presenting additional scientific information about abaloparatide as part of the American Society for Bone Mineral Research (ASBMR) Annual Meeting in Atlanta, Georgia September 16-19, 2016.”
Abaloparatide is still an investigational treatment and its safety and efficacy have not been established. A New Drug Application is currently under review by the FDA.
Access the online JAMA manuscript: http://jama.jamanetwork.com/article.aspx?doi=10.1001/jama.2016.11136
The Phase 3 ACTIVE trial was a randomized, double-blind, placebo-controlled, comparative, multicenter, 18-month international study in 2,463 postmenopausal women with osteoporosis designed to evaluate the efficacy and safety of the investigational drug abaloparatide-SC 80 mcg to reduce the risk of vertebral and nonvertebral fractures.
Radius is a science-driven biopharmaceutical company that develops innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases. Radius’ lead product candidate, the investigational drug abaloparatide for subcutaneous injection, has completed Phase 3 development for potential use in the reduction of fracture risk in postmenopausal women with osteoporosis.
Radius’ Marketing Authorisation Application (MAA) for abaloparatide-SC is under regulatory review in Europe and a New Drug Application (NDA) has been accepted for filing by the FDA with a PDUFA date of March 30, 2017.
The Radius clinical pipeline also includes an investigational abaloparatide transdermal patch for potential use in osteoporosis and the investigational drug RAD1901 for potential use in hormone-driven and/or hormone-resistant breast cancer, and vasomotor symptoms in postmenopausal women. Radius’ preclinical pipeline includes RAD140, a non-steroidal, selective androgen receptor modulator (SARM) under investigation for potential use in cancer.
For more information, please visit www.radiuspharm.com
Osteoporosis is an important and serious disease that affects not only postmenopausal women but also men, causing bone fractures in both men and women. Many believe that the disease is underdiagnosed and not effectively treated by just few marketed drugs that many physicians are reluctant to use because of their side effects and inefficacy in preventing bone fractures or treating them when they occur. Amgen has come up with a drug, denosumab, which has also shown efficacy in delaying cancer metastasis into the bone. The same firm has a new osteoporosis drug expected to be soon approved (see previous Prohost articles on the subject).
Regarding Radius Health’s drug abaloparatide-SC, we believe it came on time as it is highly required to give osteoporosis patients more treatment options, in addition to a missing option that might give them hope in preventing bone fractures and healing them when they occur.
Nothing is said about it yet.
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