J&J’s Spravato Gets EU Okay For Drug-Resistant Depression

Concerns that written interventions might delay the expected EU approval of the novel ketamine-based antidepressant have come to naught.

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The European Commission has approved Janssen Pharmaceutical Cos.’s therapy for drug-resistant depression, Spravato (esketamine), allaying fears that written interventions from third parties may have delayed matters.

The nasal spray has been granted a label for use in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI), for adults living with treatment-resistant major depressive disorder (TRD) who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode. This is in line with its CHMP positive opinion back in October.

While controversial for its close relationship to the illicit party drug ketamine, the selective NMDA receptor modulator offers the first new mechanism of action to treat in 30 years to treat major depressive disorder (MDD). Spravato won US approval in March.

The positive opinion was based on five Phase III trials and J&J noted that in one of them, a one-month study, approximately 70% of all esketamine-treated patients responded to treatment with a greater than 50% symptom reduction. Furthermore, the company said around half of all treated patients achieved remission, with few, if any, symptoms of depression, “which is the ultimate treatment goal." However, since the opinion it emerged that the European Medicines Agency received “written interventions” from third parties relating to the agency’s October recommendation.

Janssen said that it was aware that the EMA had “received correspondence from third parties” on Spravato following the adoption of the positive opinion, but said it believed in the “strength of the centralized regulatory review process.” (Also see "EU Approval Delay for Janssen’s Spravato?" - Scrip, 17 Dec, 2019.)

Final CHMP opinions are not legally binding on the commission. However, while the latter may diverge from the decisions reached by the CHMP – even in the absence of a third-party intervention – this rarely happens, and in this case the EC has followed the committee’s recommendation.

In the US, where Spravato had fast-track and breakthrough therapy designations, it was approved with a restrictive risk management plan, along with a commitment by the company to undertake a monotherapy efficacy trial, a decision that was questioned in some quarters.

Janssen has not confirmed when it will start roll out of Spravato in Europe although in the UK Spravato is initially likely to be made available through private clinics. The National Institute for Health and Care Excellence is scheduled to make a decision on whether to approve the drug for use on the National Health Service in March next year.