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Janssen submits esketamine in Europe for treatment resistant depression

Fast-acting drug would be first new treatment for refractory disease in 50 years

Janssen has filed its new nasal spray-administered treatment for treatment resistant depression with the European Medicines Agency (EMA).

Esketamine is a glutamate receptor modulator, for treatment-resistant depression (TRD) in adults with Major Depressive Disorder (MDD).

It has been developed for patients who have failed to respond to at least two different treatments with antidepressants in a moderate to severe depressive episode – a group which represents up to 30% of patients.

Filed with the FDA last month, the US regulator is now scheduled to make its ruling in May 2019.

Having gained two FDA breakthrough therapy designations (one in TRD, the other in MDD with imminent risk for suicide), analysts had expected big things from the novel therapy.

However analysts at Evaluate say concerns that the drug might activate opioid receptors in the brain – and therefore be an addiction risk – could lead to the FDA imposing warnings or restrictions on its use.

It also says ‘underwhelming’ phase 3 results have led to its sales forecast being downgraded significantly - now standing at $490m annual revenues by 2022.

The drug is a rapidly-acting antidepressant, and is thought to work by restoring synaptic connections in brain cells in people with TRD.

Janssen (J&J’s pharma division) says this novel mechanism of action could help patients where other treatments have failed.

The filing is based on five pivotal phase 3 studies of esketamine nasal spray in patients with TRD: three short-term studies, one randomised withdrawal and maintenance of effect study, and one long-term safety study.

Data from these phase 3 studies showed treatment with esketamine nasal spray plus a newly initiated oral antidepressant, compared to an active comparator (newly initiated antidepressant plus placebo nasal spray), was associated with rapid reduction of depressive symptoms, as early as day two, and reduced the risk of relapse by 51% in stable remitters.

Mathai Mammen

Mathai Mammen

“Major Depressive Disorder 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,” said Mathai Mammen, M.D., Ph.D., global head, Janssen Research & Development.

Allergan also has a contender in phase 3 trials, rapastinel, and is likely to be free of the dependency risk of Janssen’s drug.  Pivotal data is expected in the first half of 2019, though it isn’t currently expected to challenge esketamine in revenue terms.

Article by
Andrew McConaghie

11th October 2018

From: Regulatory

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