Axsome's migraine drug issued CRL a week after the biotech outlined CMC concerns
A week after New York-based Axsome Therapeutics said it expected a CRL for its migraine drug, the biotech reported Monday that the FDA has followed through.
The principal reasons given in the CRL are related to chemistry, manufacturing and controls (CMC) considerations, Axsome reiterated Monday. The letter identified the need for some additional CMC data about the drug product itself as well as the manufacturing process, according to Axsome. The biotech believes the issues raised can be addressed and intends to provide potential timing for a resubmission following consultation with the FDA. The letter did not raise any efficacy issues, Axsome said.
“It is our goal to work with the FDA to fully understand and adequately address their comments so that we can make this important new medicine available to patients with migraine as quickly as possible,” said Axsome CEO Herriot Tabuteau in a statement. “The approval of AXS-07 would offer a much-needed new multi-mechanistic treatment option for the millions of people living with this debilitating neurological condition.”
Though the drug received a rejection, the biotech’s stock price $AXSM stayed positive with a roughly 3% increase in early Monday trading, but it remains down about 16% from last week.
Per previous reporting on the AXS-07 saga, Axsome said the NDA is to be delayed by about a year, with six months to correct the issues and six months for FDA to re-review, according to investment analysts at William Blair. Analysts at Cowen said that the drug, dubbed AXS-07, has generated two positive pivotal studies in the treatment of acute migraines in addition to a long-term follow-up trial with patients seeing rapid and sustained pain relief.
They also believe that if Axsome gets over the hill on the FDA front, the medicine could serve as a viable therapy and a potential moneymaker.
The therapy itself is an oral medicine for the acute treatment of migraines and consists of the company’s MoSEIC technology as well as meloxicam and rizatriptan.
Axsome is no stranger to going back to the drawing board with the FDA. Back in 2020, after clearing a late-stage study, Axsome’s AXS-05 therapy, meant to treat major depressive disorder, also faced several challenges. The drug then failed to meet its main goal for the AXS-05 pill, delaying any further action.
In 2021, the FDA laid out its concerns with AXS-05 in a letter, outlining how FDA had identified deficiencies that preclude labeling discussions with Axsome. After the biotech re-submitted its application, the drug appears to be back on the cusp of approval again.