NBC reports on a pretty shoddy FDA approval process for Janssen’s new, trailblazing drug for treating depression — Spravato.
Spravato is a nasal-spray that uses esketamine, which is a cousin of ketamine.
NBC News notes that Janssen didn’t even provide safety information for drug use beyond 60 weeks (!), and seemed to ignore the fact that 3 users committed suicide during trials, compared to 0 in the placebo groups.
Dr. Jess Fiedorowicz, director of the Mood Disorders Center at the University of Iowa and a member of the FDA advisory committee that reviewed the drug, described its benefit as “almost certainly exaggerated” after hearing the evidence.
Fiedorowicz said he expected at least a split decision by the committee. “And then it went strongly in favor, which surprised me,” he said in an interview.
Esketamine’s trajectory to approval shows — step by step — how drugmakers can take advantage of shortcuts in the FDA process with the agency’s blessing and maneuver through safety and efficacy reviews to bring a lucrative drug to market.
As the article notes, the drug is a windfall for Janssen. They’re charging $4,700 for the first month of treatment.
