Mar 7 2014, 5:58pm CST | by Forbes
In the last few years the PCSK9 inhibitors have been one of the few bright lights in an otherwise dismal field of new cardiovascular drugs. Now the FDA is raising questions that could dramatically slow down the progress of these new cholesterol-lowering drugs.
Last month Regeneron disclosed that it had been “advised by the FDA that it has become aware of neurocognitive adverse events in the PCSK9 inhibitor class. The FDA requested that Regeneron and its partner, Sanofi, “make an assessment of potential neurocognitive adverse events across the global development program” of their PCSK9 inhibitor, alirocumab. Regeneron and Sanofi said they were “not aware of any neurocognitive adverse event signal relating to alirocumab” but warned that “if this or another adverse event signal is detected, the further development of alirocumab may be delayed or fail, or its commercial value diminished.”
No one remarked on the statement last month when it was buried in the Regeneron annual report. But when the same statement was discovered today in Sanofi’s annual report, a Twitter storm ensued, and the companies’ stocks, as well as Amgen’s (which is also developing a PCSK9 inhibitor) took significant hits.
Reporters and analysts asked around but found no obvious source for the FDA’s concerns. Regeneron, Sanofi, Amgen, and Pfizer all denied finding any signal for neurocognitive adverse events in their data.
Short of the remote possibility that neurocognitive adverse events could scuttle the entire class of drugs, a more likely problem is that these concerns could result in serious delays in the approval of these drugs, which many thought were on a smooth path to approval. Most ominously, the companies said that the FDA asked “about the feasibility of incorporating neurocognitive testing into at least a subset of patients” in clinical trials. The conventional wisdom has been that the PCSK9 inhibitors will be able to gain approval before the completion of outcome studies. The concern now is that the FDA will insist that these studies be completed before the drugs can be approved.
Source: Forbes Business
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