Bristol-Myers Squibb's Abilify seen as 'approvable' by FDA

Published: 18-Sep-2002
Regulatory


Bristol-Myers Squibb and Japan's Otsuka Pharmaceuticals have received an approvable letter from the FDA for their new-generation antipsychotic compound aripiprazole. However, final approval still depends on ongoing discussions. The product, which is tentatively known as Abilify, was filed with the FDA in October last year.

B-MS and Otsuka say that it has a different mechanism of action from currently available antipsychotics and may help reduce the level of side-effects experienced by schizophrenics. This profile may enable it to compete effectively against the big players, such as Eli Lilly's Zyprexa, in a multi-billion dollar market.

B-MS chairman Peter Dolan said that the approvable letter was a 'significant milestone' for the product. However, it is clearly also an important development for the firm itself, which has had a dismal year so far. This year has also seen the anti-hypertensive Vanlev, a potential blockbuster for the firm, knocked by an FDA panel on safety concerns, generics erosion of several key products and an investigation into partner ImClone concerning clinical trials of the cancer drug Erbitux.

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