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Allergan and Gedeon finally get antipsychotic green light

Antipsychotic drug Vryalar launches into increasingly competitive market
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After a two-year delay, Allergan and Gedeon Richter have finally gained approval in the US for Vraylar, their new drug to treat schizophrenia and bipolar disorder.

Vraylar (cariprazine) is a dopamine D2, D3 receptor partial agonist and was turned down by the FDA in 2013, with the agency requesting more data including another clinical trial despite acknowledging that the drug was effective.

The FDA wanted another trial to provide information on optimal dosing for the oral, once-daily drug that would maintain efficacy whist also minimising the risk of side effects. After that data was filed, the agency also claimed a three-month extension to its review period to assess what it described as a major amendment to the dossier.

Approval was based on clinical trials involving around 2,700 patients, which showed that the drug was more effective than placebo at improving two symptom scales widely-used in bipolar disorder and schizophrenia studies.

Vraylar is launching into an increasingly competitive market for antipsychotic drugs, which has seen several former blockbusters lose patent protection in the last few years, and the new product is expected to have a challenging time carving out a niche.

Many of these were oral drugs, and there has been a shift of late by pharma manufacturers towards the development of long-acting depot injections which can reduce the risk of patient's relapsing because they forget or choose not to take their daily medication.

Once-monthly examples include Otsuka/Lundbeck's Abilify Maintena (aripiprazole) and Johnson and Johnson's Invega Sustenna (paliperidone palmitate), while J&J is also developing a three-monthly paliperidone depot that has been submitted for approval and is also expected to shake up the market.

Nevertheless, "it is important to have a variety of treatment options available to patients with mental illnesses so that treatment plans can be tailored to meet a patient's individual needs," said the FDA's Mitchell Mathis, who is director of the Division of Psychiatry Products in the agency's Centre for Drug Evaluation and Research (CDER).

Analysts at Canaccord Genuity have indicated they expect cariprazine to have annual peak sales potential of around $500m. It will reach the market shortly after another orally-active rival - Otsuka/Lundbeck's Rexulti (brexpiprazole), which is being positioned as having a better side effect profile than other antipsychotics and has been tipped to become a blockbuster.

Article by
Phil Taylor

21st September 2015

From: Regulatory

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