Amgen Drug Wins FDA Approval for Sale

US Food and Drug Administration granted permission to Amgen Inc for the sale of osteoporosis drug Prolia, which is capable of preventing fractures in post-menopausal women, on Tuesday.

The drug, also known as denosumab, has been identified as the most important growth booster. On a good note for the Company, FDA’s approval has come 2 months in advance to the expected date for the approval.

Following FDA’s announcement, Amgen’s shares surged by more than 4% in after-hours trading.

The Company shared that it will launch the drug in the markets within the nearly two weeks at a retail price of 825 per 60 milligram injection.

Prolia is to be provided to the patient one in 6 months. It functions by reducing the destruction of the bones and increasing bone mass. It also reduces the strength of those proteins which activate bone-destroying cells.

"Denosumab is the most potent agent ever introduced into clinical practice that blocks bone degradation," Roger Perlmutter, Amgen's Research Chief.

As per the estimations of the analysts, the annual global sales of Prolia will hit $3.3 billion in 2014.

Cowen and Co analyst Eric Schmidt said that they had expected the early approval of the drug. Its sales will grow gradually in the commercial sector.