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Home Industry News Amgen required to offer further information on Prolia

Amgen required to offer further information on Prolia

20th October 2009

Amgen has received a complete response letter from the Food and Drug Administration (FDA), requesting that it discloses further information on the biologic license application for Prolia (denosumab).

The drug, which is intended for the treatment and prevention of postmenopausal osteoporosis, is to undergo further examination by the FDA, which has requested additional details on the design of Amgen’s previously submitted post-marketing surveillance programme.

However, the response does not call for additional pre-marketing clinical trials to complete the review of the treatment indication, Amgen revealed.

“We are confident that we can quickly respond to the FDA’s requests for the treatment of postmenopausal osteoporosis indication and plan to do so in the near term,” commented Roger Perlmutter, the executive vice-president of research and development at Amgen.

In other Amgen news, the firm announced that it will present data from a trial into the performance of its rheumatoid arthritis treatment Enbrel (etanercept) at an arthritis meeting this week.

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