It's CRL Day at the FDA as Axsome, Junshi and Coherus Get Bad News

FDA Stop_Sarah Silbiger/Getty Images

Sarah Silbiger/Getty Images

The U.S. Food and Drug Administration is quickly catching up after COVID-19 disrupted typical review timelines and planned inspections and it's bad news for three companies. Junshi Biosciences and Coherus Biosciences received a Complete Response Letter (CRL) after applying for commercialization of their star biologic, while Axsome Therapeutics received a CRL for its acute migraine treatment, AXS-07.

Junshi Biosciences and Coherus Biosciences

Junshi and Coherus jointly issued a press release regarding the CRL, detailing the changes that the agency would like to see before making a formal decision about the approval of toripalimab, a therapeutic for patients with nasopharyngeal carcinoma (NPC). After addressing the requested quality process change, a Biologics Licensing Application (BLA) will be refiled for the therapeutic in hopes of being able to bring treatment options to an area of medicine with a previously unmet need.

Roadblocks remain for the collaboration’s effort to bring toripalimab to commercialization, as the COVID-19 pandemic is still rampant in China. Despite the challenges, the companies laid out an ambitious timeline. Between addressing the changes and refiling the BLA, all matters are estimated to be wrapped up by mid-summer 2022.

Coherus CEO Denny Lanfear commented on the company’s short-term strategy.

“The FDA has indicated that the existing toripalimab clinical data are supportive of the BLA submission, and we eagerly await scheduling and completion of the required inspections in China that have been impeded to date by COVID-related travel restrictions," he said in a statement. "We believe toripalimab addresses an important unmet need for patients with NPC for whom there are currently no approved immunotherapies in the United States, and the FDA has stated that this indication warrants regulatory flexibility with respect to the sufficiency of single country clinical data.”

Axsome Therapeutics

Axsome Therapeutics will also use the FDA communication channels that are readily available to all product sponsors in an effort to expedite the resolution of chemistry, manufacturing and controls (CMC) data-related concerns.

The company’s CEO, Herriot Tabuteau, M.D. commented on the letter, with mention of a philanthropic goal.

"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. 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," he said. 

AXS-07 is an orally administered, fast-acting treatment for migraines, using rizatriptan in conjunction with meloxicam that is formulated using Axsome’s molecular solubility enhanced inclusion complex (MoSEIC) technology.

While treatment options for migraine sufferers have expanded in the last decade, the press release quotes a statistic that evaluates patient satisfaction with their current regimen: “Published surveys of migraine sufferers indicate that more than 70% are not fully satisfied with their current treatment, that nearly 80% would try a new therapy, and that they desire treatments that work faster, more consistently, and result in less symptom recurrence.”

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