Radius Health (NASDAQ:RDUS) has announced that the FDA has approved removing a boxed warning from the label of Tymlos, an osteoporosis drug.
The warning had described a risk of osteosarcoma, a type of bone cancer.
The agency reviewed long-term post-marketing data related to the drug and the broader class of related parathyroid hormone (PTH) drugs.
“This is an important update to the Tymlos label,” said Dr. Bruce Mitlak, the chief medical officer of Radius, in a statement. “Achieving this result was made possible by FDA analysis of a significant amount of data that had been generated over many years.”
The FDA first approved Tymlos (abaloparatide) as an osteoporosis treatment in individuals with a high fracture risk.
RDUS shares ticked up 2% on December 24 to $7.14.
Filed Under: clinical trials, Drug Discovery
Tell Us What You Think!
You must be logged in to post a comment.