Federal regulators Friday approved a new drug developed by a Waltham company to treat post-menopausal women with osteoporosis who are at high risk for bone fractures.
The injectable hormonal treatment, which will be marketed by Radius Health Inc. under the brand name Tymlos, reduces the risk of some types of fractures. It will be the first new bone-building hormone in more than a decade for osteoporosis in post-menopausal women.
Tymlos, which will be launched in May, was approved by the Food and Drug Administration two months before its scheduled date for a decision. The drug will be the first commercial product for Radius, a 13-year-old biotech that went public in 2014.
“Tymlos is a very important opportunity for physicians to have a new tool to consider for post-menopausal women at high risk for osteoporotic fracture,” said Radius chief executive Bob Ward.
Radius didn’t immediately disclose how much it will charge for the drug, which significantly reduced the risk of bone fractures in clinical trials. Ward said the company expects to discuss the price in a webcast with analysts scheduled for Monday.
The market for the new Radius treatment, which will compete with an Eli Lilly & Co. drug already being sold commercially, is potentially large. An estimated 8 million US women have osteoporosis, a bone-depleting condition, and another 44 million may have low bone mass, placing them at increased risk for osteoporosis.
Approval of the treatment included safety warnings of side effects ranging from dizziness and nausea to fatigue and palpitations. When given in large doses to male and female rats, Tymlos increased the incidence of malignant bone tumor, though it’s not known if it could cause tumors in humans.Robert Weisman can be reached at firstname.lastname@example.org. Follow him on Twitter @GlobeRobW.