FDA clears new formulation of Bristol-Myers Squibb's arthritis drug Orencia

Bristol-Myers Squibb said Friday that US regulators approved a subcutaneous formulation of Orencia (abatacept) to treat adults with moderate to severe rheumatoid arthritis. The company indicated that the new self injectable formulation of the drug will be available in September.

The drugmaker noted that in the ACQUIRE study involving 1457 patients, the subcutaneous formulation of the drug showed "similar efficacy" and safety at six months to the intravenous form, which was cleared by the FDA in 2005. Last year, the agency put its consideration of the new Orencia formulation on hold after it issued a warning letter regarding deficiencies at Bristol-Myer Squibb's manufacturing plant in Puerto Rico. The company announced in June that the regulator was satisfied with the corrections it made.

Second-quarter sales of Orencia, which is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis, rose 28 percent to $228 million.

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