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J&J gets EU approval for depression nasal spray Spravato

Approved with a risk management plan to guard dosing

Spravato

Johnson & Johnson can market its treatment-resistant depression drug Spravato on both sides of the Atlantic, now that the EMA has followed the FDA in approving the drug.

J&J’s pharma division Janssen says Spravato (esketamine) is the first antidepressant medicine with a new mechanism of action to reach the European market in more than 30 years.

As in the US, it has been approved by the EMA for use alongside conventional oral antidepressants in adults who have not responded to treatment with at least two lines of therapy with oral selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI) drugs alone.

Spravato is also approved with a risk management plan designed to monitor patients carefully after dosing, to guard against drug abuse of the ketamine-derived therapy as well as other side effects like disturbances in consciousness, transient dissociative states and perception disorders.

Esketamine is a glutamate NMDA receptor modulator, and is of particular interest to clinicians because it starts to work much more quickly than current antidepressants, which can take several weeks to kick in. It is given at much lower doses than ketamine, a notorious illegal recreational drug.

The European marketing authorisation is based on data from five phase 3 trials that involved more than 1,600 patients and included three short-term studies, one randomised withdrawal and maintenance of effect study, and one long-term safety study.

A one-month flexible dosing study in adults under 65 years of age demonstrated statistically significant reductions in depressive symptoms at 28 days with Spravato versus placebo, with around 70% of patients on J&J’s drug responding with a 50% or greater symptom reduction.

Approximately half of all Spravato patients achieved remission at the end of the four-week study with few, if any, symptoms of depression, which is the ultimate treatment goal.

The EMA has backed the drug despite some mixed results in trials, as well as some last-minute opposition to the approval in the form of written interventions to the regulator.

Mental health experts wrote to the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK to argue that the drug should not be approved, on the grounds that the evidence for its efficacy isn’t strong, it carries a risk of dependency, and that its psychoactive effects mean that subjects in trials would have been aware they were on an active drug and not placebo.

Those comments didn’t sway the EMA, and Janssen is now free to roll it out across Europe once pricing negotiations with individual countries are completed. In the US the drug costs $6,785 for the first month and $3,450 thereafter, and that has already attracted criticism from the Institute for Clinical and Economic Review (ICER).

In the UK, the National Institute for Clinical and Healthcare Excellence (NICE) is due to deliver its verdict on the drug’s cost-effectiveness in March 2020.

“This new treatment represents an exciting new therapeutic option for a common, debilitating and difficult to treat condition,” said Professor Allan Young, director of the Centre for Affective Disorders at King’s College London.

“I believe both clinicians and patients will welcome this treatment option for this often-devastating illness,” he added.

Article by
Phil Taylor

20th December 2019

From: Regulatory

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