Amgen ($AMGN) has gotten an FDA approval for an expanded use of its drug Xgeva, just not the one it covets most. The drug was approved Thursday for treatment of the rare giant cell tumor of the bone (GCTB).
The approval is for use of the drug by adults and "skeletally mature" adolescents when they can't be treated with surgery. The condition is generally not cancerous, but the tumor is destructive to bones. The agency gave it priority review. "Advances in our understanding of the underlying biology of this rare disorder have allowed Amgen to generate compelling clinical evidence to address the medical needs of patients and their healthcare providers," said Dr. Sean E. Harper, executive vice president of research and development at Amgen.
The drug is already approved in the U.S. to delay fractures and stave off tumor growth in patients who have developed bone metastases. The drug also is sold as Prolia for the prevention of fractures in postmenopausal women with osteoporosis. But the FDA last year turned down Amgen's application for Xgeva's use for advanced prostate cancer patients to prevent or delay the disease's spread to the bone. That is a much larger market, but the agency said the company would need to return with more data.
Amgen is looking to Xgeva, which brought in about $750 million last year, to help boost earnings as sales of some of its other products, like the anemia drugs Epogen and Aranesp, have fallen. In February, the company said it was axing 160 jobs to "adjust staffing levels to meet the needs of business." Sales of Xgeva in the first quarter were up 46% to nearly $225 million, suggesting it could hit blockbuster status this year if it continues on that trajectory.
- here's the release
- here's the FDA announcement