FDA approves Amgen’s drug Prolia, a potential blockbuster therapy for osteoporosis

FDA clears Amgen’s bone-strengthening drug, Prolia

WASHINGTON — The Food and Drug Administration on Tuesday approved Amgen’s bone strengthening drug, Prolia, for postmenopausal women at risk for fractures, a potential blockbuster market.

The injectable drug is given once every six months to increase bone mass and strength.

Analysts think Prolia should bring Amgen billions in revenue after it is launched. Sales of the company’s former top sellers, the anemia drugs, Aranesp and Epogen, have dropped in recent years due to safety concerns and label restrictions.

Pill-based osteoporosis drugs, such as Fosamax and Zometa, have been available for more than a decade. But Amgen Executive Vice President Dr. Roger Perlmutter said many women can’t tolerate those drugs or have trouble remembering to take a daily medication.

Amgen said in a statement that Prolia is the first drug to target a cellular pathway that breaks down bones.

One out of every two women over age 50 will break a bone in their lifetime due to osteoporosis, which causes bones to become brittle, according to an FDA statement.

An analysis cited by Amgen estimates that osteoporosis-related fractures will cost the U.S. health care system $25 billion annually by 2025.

FDA approved the drug based on a 7,000 patient study conducted by Amgen that showed reduced vertebrae and hip fractures in postmenopausal women.

Common side effects with the drug included back pain, high cholesterol and urinary bladder infections.

Thousand Oaks, Calif.-based Amgen will be required to distribute patient guides explaining the drug’s risks.

Global sales of osteoporosis treatments topped $8 billion last year, including hundreds of vitamin brands and drugs like GlaxoSmithKline PLC’s Boniva and Merck & Co. Inc.’s Fosamax.

With eight other pills and injectable medicines on the market, analysts say Prolia’s success likely will hinge on its price.

Prolia will cost $825 per injection, which the Amgen says is competitive with existing treatments.

Shares of Amgen rose $1.74, or 3.4 percent, to $50.76 in afterhours trading.

(This version CORRECTS Corrects price to ‘$825′ in second to last graph; ADDS detail and UPDATES stock.)