J&J’s Janssen Gets CHMP Positive Option for Spravato

Johnson & Johnson’s (JNJ) Janssen Pharmaceutical Cos. unit on Friday said the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval of its Spravato nasal spray for adults with treatment-resistant major depressive disorder.
The drug maker said the recommendation covers Spravato in combination with a selective serotonin reuptake inhibitor or serotonin and norepinephrine reuptake inhibitor for adults with treatment-resistant depression, meaning they haven’t responded to at least two different treatments.
The European Commission, which generally follows the CHMP’s recommendations, is expected to make a final decision by the end of the year, Janssen said.
The U.S. Food and Drug Administration in March approved Spravato for patients with treatment-resistant depression. The nasal spray is a close chemical relation to ketamine, an anesthetic that is often abused as a party drug but has been shown to have a fast-acting impact on depression symptoms.

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