Amgen's Prolia BLS delayed by FDA call for more info

US biotechnology major Amgen has received a Food and Drug Administration 'Complete Response' letter for its Biologic License Application for Prolia (denosumab) in the treatment and prevention of postmenopausal osteoporosis, requesting additional information needed to complete the review of applications for product approval.

The FDA requested several things, including further information on the design of Amgen's previously-submitted post-marketing surveillance program, but it does not require additional pre-marketing clinical trials to complete the review of the treatment indication, the company notes. The agency has requested a new clinical program to support approval of Prolia for the prevention of postmenopausal osteoporosis indication.

The FDA has determined that a Risk Evaluation and Mitigation Strategy (REMS) is necessary for Prolia and must include a medication guide, a communication plan, and a timetable for submission of assessments of the REMS. It has acknowledged receipt of Amgen's previously-submitted proposed REMS materials, but has also requested all updated safety data related to Prolia.
Amgen is reviewing the letter and will work with the FDA to determine the appropriate next steps regarding these applications. The company expects to receive a separate response for its application for Prolia in the treatment and prevention of bone loss due to hormone ablation in breast and prostate cancer patients.

Amgen also has submitted Prolia for approval in post-menopausal osteoporosis and bone loss in breast and prostate cancer patients due to hormone ablation therapy in the European Union, Switzerland, Australia and Canada.
In August, an advisory committee to the FDA had voted 15-0 in favor of approval of denosumab to treat osteoporosis, but 12-3 against approval for preventing it.

Meantime, according to TheStreet news service, Citibank analyst Yaron Werber has issued a research note calling investor expectations for Prolia's commercial prospects in osteoporosis too high. "Based on our analyses, we believe that our below the Street estimates are more reasonable and that Street estimates need to be reduced. This will likely cap the near-term upside in the stock," he writes. Mr Werber has a hold rating on Amgen with a $68 price target. Amgen's shares were off 3% at $59.31 in pre-market trading on October 19. The stock closed down 1.8% at $60.24 on October 19.

Long delay not expected

According to the New York Times, analysts generally said they expected Amgen would be able to satisfy the FDA's requirements fairly soon. Geoffrey Meacham of JP Morgan said the agency's request 'doesn't look onerous,' and he predicted the drug could be approved by the first quarter of 2010. Joshua Schimmer of Leerink Swann forecast a delay of five to 10 months, which would mean approval around the middle of next year.