New schizophrenia drug Abilify gets European go-ahead
pharmafile | June 10, 2004 | News story | |
Abilify, Bristol-Myers Squibb and Otsuka's antipsychotic has received European Union marketing approval and will be promoted for having fewer side effects than existing treatments, including increased risk of developing diabetes.
The lack of serious side effects seen in Abilify patients has been the leading marketing drive behind Abilify since its launch in the US at the end of 2002, a tactic which has capitalised on growing doubts about top sellers such as Lilly's Zyprexa and Jannsen-Cilag's Risperdal.
A number of studies published over the last 12 months have linked the atypical antipsychotic class of drugs to increased weight gain and increased risk of diabetes, the FDA compelling all manufacturers to add warnings to the labelling of their products in March this year, including Abilify.
BMS and Pfizer, who market Geodon, both objected to the class-wide labelling, and continue to point out there is no evidence to suggest the same side effects are seen in their products.
BMS and Otsuka continue to promote the lack of weight gain seen in Abilify patients to US doctors. A survey commissioned by the companies last year by electronic network ePocrates found 87% of psychiatrists surveyed said they would prescribe the drug more following a head-to-head which showed far fewer patients gained weight on Abilify compared to Zyprexa.
Welcoming the European approval, Otsuka president and representative director, Tatsuo Higuchi said: "For patients with schizophrenia, Abilify has a unique pharmacology among the atypical antipsychotics and has demonstrated proven efficacy with a comprehensive tolerability and safety profile."
He added that the launch of the drug would help provide the Japanese company with stronger foundations to introduce further innovative medicines in European markets.
Abilify works by inhibiting a brain receptor for dopamine, a key neurotransmitter that is overactive in the brains of people with schizophrenia.
Unlike other atypical antipsychotics, Abilify does not fully block or stimulate the receptors, but does a little of both, resulting in fewer side effects than other drugs in its class, according to a study presented by BMS to the American Psychiatric Association.
