The FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) and Drug Safety and Risk Management (DSaRM) Advisory Committee met on February 12, 2019 to consider Janssen’s NDA for its esketamine nasal spray for the treatment of treatment-resistant depression in adults and voted in favor of approval.
On the question, “Has the Applicant provided substantial evidence of the effectiveness of esketamine for the treatment of treatment-resistant depression?” the vote was 14 yes, 2 no, with one abstention.
On the question, “Has the Applicant adequately characterized the safety profile of esketamine for the treatment of treatment-resistant depression?” the vote was 15 yes, 2 no.
Janssen, which is now calling the nasal spray “Spravato,” submitted the NDA for the product in September 2018. The PDUFA date for the FDA to complete its review of the Spravato NDA is March 4, 2019.
Janssen Research & Development Global Head, Neuroscience Therapeutic Area, Husseini K. Manji 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. Our comprehensive research program for esketamine nasal spray supports a positive benefit-risk profile for adults with treatment-resistant depression.”
Read the Janssen press release.
