Bristol-Myers Squibb and partner Otsuka Pharmaceutical of Japan have been boosted by a new approval from US regulators for their schizophrenia drug Abilify.

The US Food and Drug Administration has given the green light to the firms’ supplemental New Drug Application for Abilify (aripiprazole) as adjunctive treatment to antidepressant therapy for adults who are suffering from major depressive disorder. It is the first medication approved by the agency as an add-on treatment for MDD.

The approval is based on two six-week studies of 743 patients, both of which demonstrated significant improvement in depressive symptoms in patients experienced an inadequate response to monotherapy with one or more antidepressants in the current episode and then added Abilify to their treatment regimens.

Abilify, an atypical antipsychotic which had third-quarter sales of $420 million, up 34%, was approved for schizophrenia in November 2002 and this new approval should keep that sales momentum going.

The approval came just as the FDA also approved an sNDA for B-MS and Sanofi-Aventis’ combination hypertension drug Avalide (irbesartan/hydrochlorothiazide). The agency has passed the drug for initial use in patients with hypertension “who are likely to need multiple drugs to achieve their blood-pressure goals”, the firms said.

The approval is based on what B-MS described as “powerful new efficacy data” from two clinical trials involving more than 1,200 patients with moderate or severe high blood pressure. In the first seven-week trial, patients were randomly treated with either Avalide 150/12.5mg or irbesartan 150mg monotherapy. All doses were doubled after a week and at five weeks, Avalide 300/25 mg showed mean blood pressure reductions of 30.8/24.0 mm Hg, compared to 21.1/19.3 mm Hg for irbesartan 300 mg alone. As for the second 12-week trial, at eight weeks, Avalide 300/25 mg demonstrated mean blood pressure reductions of 27.1/14.6 mm Hg, which was significantly greater than irbesartan 300 mg or hydrochlorothiazide 25mg alone.

Meantime, analysts at Cowen & Co have upgraded B-MS to ‘neutral,’ saying that it is based on soon-to-be disclosed details about the company’s streamlining initiatives and product mix. B-MS is holding a meeting with analysts on December 5 when specifics will be revealed but analysts at UBS have issued a research note saying that the measures may include a potential consolidation of the firm’s manufacturing segment to below 50% of its existing 38 sites and a headcount reduction of 10%-20%. B-MS is expected to generate $1-$1.5 billion in savings over the next three years.