In an unprecedented move, the Food and Drug Administration rescinded a recent decision that an Alkermes (ALKS) drug being developed for treating depression would not be reviewed. And the sudden reversal is raising questions about the extent to which the agency is willing to become more flexible about drug approvals in an overheated political climate focused on access to medicines.
Here’s the backstory: On April 2, the company unexpectedly disclosed that the FDA issued a so-called refuse-to-file letter, which meant the marketing application for its drug would not be reviewed. Why? There was “insufficient evidence of overall effectiveness” in treatment-resistant depression, and the agency wanted additional “well-controlled clinical trials.”
At the time, the decision was seen not only as a rebuke to Alkermes, but also a referendum on the willingness of the FDA to approve drugs based, in part, on data from failed clinical trials. As STAT noted, two of three studies submitted to the agency failed to hit primary endpoints, but Alkermes argued the “totality” of the data showed that the drug, dubbed ALKS-5461, was effective.