By John Ogg
Amgen Inc. (AMGN) shares actually held up quite a bit better today than many investors might have guessed considering an FDA delay.
The biotech giant was on deck for an FDA decision due no later than today on its Prolia drug for the treatment and prevention of postmenopausal osteoporosis. Unfortunately, the FDA issued a Complete Response Letter regarding Amgen’s pending Biologic License Applications (BLA) for Prolia, which has effectively delayed the FDA’s decision to approve the drug with a request for more information.
Prolia is believed to have blockbuster potential, crossing the $1 billion in annual sales mark. This situation is a complicated one, but things could have been much worse, as this was just one aspect of Prolia.
The reason that shares of Amgen are ‘only’ down 1.5% to $60.24 is because many investors were expecting a more harsh response. Most still believe that Amgen will get this drug approved.
The FDA is requesting additional data, and it does not appear that Amgen has to go back to re-do studies. The FDA requested further information on the design of the previously-submitted post-marketing surveillance program, but it does not require Amgen to go back for additional pre-marketing clinical trials to complete the review of the treatment indication. Technically, this is almost good news.
The FDA did request a new clinical program to support approval for the prevention of postmenopausal osteoporosis indication, and it determined that a Risk Evaluation and Mitigation Strategy is necessary for Prolia. This new data must include a medication guide, Amgen’s communication plan and a timetable for submission of assessments. But the FDA acknowledged receipt of Amgen’s previously-submitted proposed REMS materials and has requested all updated safety data related to Prolia. Amgen confirmed that it is reviewing the FDA’s response and “will work with the FDA to determine the appropriate next steps regarding these applications.”
Amgen still expects to receive a separate response for its currently-pending application for Prolia as a treatment and prevention of bone loss due to hormone ablation in breast and prostate cancer patients.
It was in August that Amgen noted that the FDA reviewed safety and efficacy data from 30 clinical studies involving more than 12,000 patients, and an FDA committee did recommend approval of Prolia for the treatment of postmenopausal osteoporosis and for the treatment of bone loss in patients undergoing hormone ablation for prostate cancer. But the committee recommended against approval of Prolia to treat or prevent bone loss in women with breast cancer undergoing hormone ablation until additional data are available. And Amgen noted that the FDA committee also recommended against approval of Prolia to prevent bone loss in low-risk patients in all three populations.
The take from your truly is that Prolia is still likely to get approval for at least one indication or two indications later in 2010 and perhaps another of three or four indications in 2011 to 2012.
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