Launch Date: June 2010 (Prolia) and December 2010 (Xgeva)
First Full-Year Sales (2011): $554 million
First-Half 2013 Sales: $802 million
Analyst Estimate for 2018: $3.368 billion
Amgen's ($AMGN) denosumab was first approved by the FDA in June 2010 under the brand name Prolia, to prevent fractures in postmenopausal women with osteoporosis. The agency again approved the same drug--albeit at a different dosage and under the Xgeva brand name--a few months later to delay fractures and stave off severe bone pain in patients with bone metastases. It was the first novel bone-targeted drug to be approved in nearly a decade.
The drug immediately started knocking out sales befitting that special status in the market and rocketing toward its projected $3.4 billion in peak sales. It grabbed more than half a billion dollars in revenue its first full year on the market and then eased past blockbuster status last year with $1.2 billion in combined Xgeva/Prolia sales. It has sold $802 million in the first half of 2013.
All of that has come without the indication Amgen had hoped to get last year: use in advanced prostate cancer patients to prevent or delay the disease's spread to the bone. That is a much larger market, but the FDA turned down its application for that indication last year and said the company would need to return with more data. Xgeva was approved in June 2013 for treatment of the rare giant cell tumor of bone (GCTB).
Amgen has been looking to this powerhouse drug to boost earnings and replace sales as some of its other products, like the anemia drugs Epogen and Aranesp, taper off. In February, the company said it was axing 160 jobs to "adjust staffing levels to meet the needs of business." But some of the pressure is off Xgeva now that Amgen is taking over Onyx Pharmaceuticals ($ONXX) for $10.4 billion. Central to that deal was the multiple myeloma drug Kyprolis, which also appears here on our list of drug launch superstars.
Amgen's Xgeva gets new approval, just not one it wants most
Amgen's new meds beat estimates as anemia drugs slip
Amgen gets a no from the FDA on extended use of Xgeva
Amgen offers promising Xgeva data on bone metastasis, pain
Amgen's Prolia wins new uses, performs in study
-- Eric Palmer (email | Twitter)