In addition to its novel mechanism of action, the Scrip judges highlighted Prolia’s efficacy in reducing fractures and dosing regimen. Prolia, the first and only RANK Ligand inhibitor approved in the U.S. and the European Union (EU), is an every six month subcutaneous injection.
Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen said, We are honored to be recognized again by our industry peers with the Best New Drug award. Only last year we were recognized by Scrip for our robust pipeline, which at the time included Prolia. This medicine is the result of more than a decade of work, beginning with Amgen’s discovery of a pathway that regulates bone metabolism and culminating in this important new treatment option for patients with bone disease.
Osteoporosis is a serious, chronic disease that affects 30 percent of postmenopausal women in the EU.(i) In the U.S., one in two women over the age of 50 with postmenopausal osteoporosis will experience a fracture in her remaining lifetime.(ii) Postmenopausal women with osteoporosis who have experienced a fracture are at increased risk for another fracture.(iii),(iv),(v)
The annual Scrip Awards are independently judged by a panel of senior industry experts and are given to biotechnology and pharmaceutical companies for their contribution to the improvement of healthcare. For more information, visit the Scrip website http://www.scripintelligence.com/awards/
Prolia is approved for use in the U.S., the EU, Canada, Australia and Switzerland. In the U.S., Prolia is approved for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Prolia reduces the incidence of vertebral, non-vertebral and hip fractures. The U.S. prescribing information indicates Prolia should be administered by a healthcare professional.