FDA approves removal of boxed warning from label for osteoporosis drug Tymlos

By Brian Buntz | January 3, 2022

Radius 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
Tagged With: abaloparatide, osteoporosis, osteosarcoma, parathyroid hormone, Tymlos

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.