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J&J files three-monthly schizophrenia drug in Europe

Hopes to gain advantage over its competitors


Johnson & Johnson has submitted a new depot formulation of its antipsychotic therapy paliperidone in Europe, shortly after the new version was approved in the US.

The drug is expected be the first and only schizophrenia treatment that can be dosed just four times a year if approved for marketing in the EU, according to J&J's Janssen-Cilag unit.

J&J sells a once-monthly version of paliperidone as Invega Sustenna in the US and Xeplion in Europe, but the reduced dosing frequency could give the franchise a competitive advantage over other once-monthly rivals such as Lilly's Zypadhera (olanzapine) and Lundbeck's Abilify Maintena (aripiprazole), launched in Europe last year.

The three-monthly version was approved by the FDA as Invega Trinza in May on the back of clinical data showing that the drug was effective, preventing significant return of schizophrenic symptoms in 93% of patients in a long-term maintenance trial. If approved, it will be marketed as Trevicta in Europe.

The reduced dosing frequency not only helps improve compliance with therapy and reduces relapse rates, but also improves patients' quality of life and -potentially - can allow doctors to move beyond focusing on treatment and towards helping patients pursue long-term personal goals.

Xeplion/Invega Sustenna is already a big earner for J&J, with sales rising more than 10% in the first six months of this year to reach $847m.

Decision Resources predicted in a recent research report that the three-monthly formulation of paliperidone will be one of the main derivers for growth in the schizophrenia market, which is predicted to grow from $5.9bn in 2013 to $6.4bn in 2017.

"This treatment has the potential to offer patients a new dosing schedule, which may result in improved care for many people with schizophrenia," said Andreas Schreiner, who heads the neuroscience and pain unit for Janssen in Europe.

"We look forward to working with the EMA to make this long-acting therapy available for the treatment of patients with schizophrenia in Europe," he added.

Article by
Phil Taylor

25th August 2015

From: Sales



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