Regulators handed Amgen two victories for its drug portfolio, granting the Thousand Oaks biotech giant approval to treat a wider range of patients with osteoporosis and blood disorders.
The U.S. Food and Drug Administration approved the use of Amgen’s immune thrombocytopenia drug Nplate for earlier use in adults Oct. 18, allowing it to be given to newly diagnosed patients or patients who haven’t responded to other treatments.
The news followed on the heels of an announcement by European regulators that its bone density boosting therapy Evenity had been recommended for expansion to include postmenopausal women with severe osteoporosis and a high risk of fracture.
Evenity has been approved for treatment in the U.S., Japan, South Korea, Canada and Australia. The recommendation by the European Medicines Agency committee reverses a negative opinion issued in June and will now go to the European Commission for approval, with a decision expected by the end of the year.
Amgen stock opened Oct. 18 at $204.11, up 5.5 percent in October, but dipped slightly in morning trading.
The Nplate approval follows new data from a 12-month Phase 2 study that showed sustained platelet responses, the company said in a news release.
“These new data are the first of their kind to prospectively examine treatment-free remission as an outcome for patients with ITP,” said David Reese, head of research and development at Amgen. “This approval will provide patients the opportunity to receive Nplate earlier in the course of their disease, potentially reducing their need for prolonged steroid use.”
—Contact Marissa Nall at [email protected]