The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Janssen’s Spravato esketamine nasal spray for use with either a selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI) for the treatment of treatment-resistant major depressive disorder, the company said. A final decision by the EC is expected by the end of 2019. Spravato has been approved in the US for the treatment of treatment-resistant depression since March 2019.
Janssen-Cilag European Therapeutic Area Lead for Mood Disorders Allitia DiBernardo said, “MDD affects approximately 40 million people across Europe and is the leading cause of disability worldwide. Of these people, about one third do not respond to currently available treatments. Janssen is committed to improving outcomes for patients with treatment-resistant major depressive disorder, and we look forward to bringing a new treatment option to people who need it most.”
Janssen Research & Development Global Head, Neuroscience Therapeutic Area, Husseini K. Manji said, “We are pleased with CHMP’s opinion and their recommendation to approve esketamine nasal spray as a potential therapy for adults living with treatment-resistant major depressive disorder. For decades there have been no new treatment options for these patients. Esketamine nasal spray represents a new way to manage TRD with a unique and novel mode of administration.”
Read the Janssen press release.
