US FDA to decide on Amgen osteoporosis drug by July

Fri Feb 19, 2010 6:28pm EST

* FDA review deadline set for July 25

* Amgen response to FDA submitted last month

LOS ANGELES Feb 19 (Reuters) - The U.S. Food and Drug Administration has accepted Amgen Inc's (AMGN.O) application for experimental osteoporosis drug Prolia and will make its approval decision by July 25, the company said on Friday.

The agency asked Amgen last October to provide additional information before it would proceed with its review and the company submitted its response in late January.

The drug, also known as denosumab, is widely considered the most important growth driver in Amgen's development pipeline -- it is also being studied as a treatment for bone complications in cancer patients.

Credit Suisse has estimated that sales of denosumab could total $3 billion by 2013.

The drug is the first in a new class designed to inhibit proteins that activate bone-destroying cells. (Reporting by Deena Beasley; Editing by Tim Dobbyn)

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