The FDA really, really doesn’t like Alkermes’ NDA for its highly touted depression drug ALKS-5461.
Gunned down by agency experts in a lopsided adcomm vote, hammered by regulators for fashioning its own questionable endpoints — against their advice — and generally trashed for running one of the worst late-stage programs on record, Alkermes $ALKS today put out word after the market closed on Friday that the drug was rejected by the FDA.
The company, which was left with characterizing the agency’s response, says that regulators want to see “additional clinical data,” meaning any new potential review will be at least two or three years away.
The company says now they plan to follow up with the FDA to see if there’s a viable path forward for a drug that Alkermes CEO Richard Pops repeatedly insisted represented a major breakthrough in the field. But after stoutly insisting that they had great overall data on the drug — raising Cain after regulators initially refused to file the application with what they had — there’s absolutely no doubt that the FDA disagrees, based on what the company has provided so far.
Surprised? Some were. The stock dropped about 5%.
Here are some of the blunt expert comments made during the advisory committee meeting:
“I don’t think there’s evidence this drug works.”
“I’m very concerned about the last minute changes.”
“A single subject drives the results so strongly.”
I’m concerned about the “lack of transparency about individual subject level data.”
One panelist objected to Alkermes’ “cherry picking” study data.
“I think there were too many changes along the way.”
“We pay the ultimate price because we’re the guinea pigs.”
“A lot more needs to be done.”
There is another Phase III that reads out in a couple of years, but analysts have put this one in the circular file.
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