(Reuters) - Johnson & Johnson’s nasal spray for depression won recommendation for approval from a European Medicines Agency (EMA) panel, the regulatory body said on Friday.
The treatment, Spravato, which is the chemical mirror image of the often-abused anesthetic ketamine, won U.S. approval in March, making it the first new type of drug for depression in more than 30 years.
However, due to the potential for abuse, Spravato was approved with a host of restrictions that included requiring the drug to be administered only in a certified medical facility.
J&J has said that over 2,000 centers in the U.S. have been certified to administer Spravato, which has been touted as an asset with blockbuster potential.
EMA’s human medicines committee (CHMP) backed the drug on Friday as a combination therapy for adults with major depressive disorder who have not benefited from prior antidepressants.
Major depressive disorder affects over 300 million people globally. About 30% to 40% of these patients fail to respond to first-line treatments such as antidepressants, most of which take at least four weeks to show an effect.
While final approvals are up to the European Commission, it generally follows the panel’s recommendation and announces its decision within a couple of months.
Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Shailesh Kuber