There's no denying that FDA advisory panels generally haven't been kind to Amgen (Nasdaq: AMGN) over the past year or so. But the drugmaker last week notched one advisory panel win, and another outcome that could be considered a draw.
Amgen's first positive outcome in recent memory from an FDA advisory panel hearing came Tuesday, after a panel voted unanimously to recommend approval of its immune thrombocytopenic purpura (ITP) treatment, Romiplostim. ITP is the cause of those purple bruises on some elderly people's arms, resulting from low blood platelet count.
The panel recommendation is nonbinding on the FDA decision scheduled for later this year. Anything is possible in the wild world of the FDA, but such a strong panel recommendation comes in conjunction with a somewhat positive FDA briefing document released prior to the hearing. In that document, the FDA noted, "The data submitted under this [marketing application] indicate that [Romiplostim] therapy is safe and effective" but "current experience (with the drug) may be inadequate to detect important safety concerns."
Almost all unapproved drugs heading into an advisory panel hearing have questions that make their odds for approval mixed. The positive Romiplostim panel hearing raises the chances that it will get approved, and most analysts predict it will bring in several hundred million dollars a year if approved, so place your bets accordingly on the FDA decision and its impact on Amgen's future.
The other Amgen panel hearing was related to its cancer-related anemia drugs, Aranesp and Procrit (marketed by partner Johnson & Johnson (NYSE: JNJ). This was the third advisory panel hearing since 2007 that Amgen has been subjected to over the safety and efficacy of its anemia drugs, after the drugs were found to be associated with poorer outcomes in some cancer patients.
What made this advisory panel hearing potentially so scary for Amgen investors is that nobody knows how far the FDA will further restrict the labels for these drugs, and the advisory panel was convened to discuss what cancer patient populations shouldn't use the drugs.
As expected after a negative study of these drugs' use in head-and-neck cancer came out early last year, the advisory panel did vote to further restrict their use in patients, but also opted to keep them on the market. I won't go so far as to call this second panel hearing a win or a loss for Amgen, that determination will be visible once the FDA decides upon the new label for the drug. But either way, Amgen got at least one win out of the FDA last week.
