An FDA advisory panel on Tuesday voted 14-2, with one abstention, that the benefits of Johnson & Johnson's investigational depression therapy Spravato (esketamine) outweigh its risks. The committee additionally voted 14-2 in favour of the effectiveness of the nasal spray and 15-2 in support of its safety. The agency is expected to issue a final decision concerning approval of the treatment by March 4.
Husseini Manji, global head of the neuroscience therapeutic area at Johnson & Johnson's, Janssen Research & Development, commented "we are pleased with the advisory committees' vote and their recommendation to approve Spravato as a potential therapy for adults living with treatment-resistant depression." The drugmaker remarked that "if approved, Spravato would provide the first new mechanism of action in 30 years to treat this debilitating mental illness."
Johnson & Johnson noted that filing of the therapy in this indication was supported in part by safety and efficacy data from five Phase III studies. The company further indicated that all the patients who participated in the late-stage studies received Spravato or placebo in addition to a newly initiated oral antidepressant at the start of the treatment phase. In study data unveiled last May, Spravato was demonstrated to significantly delay time to relapse versus placebo.
Ahead of the panel vote, Carter Gould, executive director of biotech equity research at UBS, stated "ultimately, we think [Spravato's] risk-benefit profile favours approval, especially in a disease paradigm where little options are available."
Spravato was previously granted breakthrough therapy designation by the FDA for the treatment of major depressive disorder with imminent risk for suicide. The therapy has also been submitted for review to regulators in Europe.
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