Orencia (abatacept) from Bristol-Myers Squibb gained U.S. regulatory approval for treating rheumatoid arthritis (RA).
BMS said the biotechnology drug should be available by the end of February.
As per its marketing policy, the drug maker will wait a year before launching DTC advertising for Orencia. Healthcare professionals will be educated about the drug first, a BMS spokesman said. The professional agency is Corbett Accel Healthcare Group, of Chicago.
Orencia is indicated for reducing the signs and symptoms of RA in adult patients with moderately to severely active RA who have had an inadequate response to one or more other treatments, which include Amgen therapy Enbrel and Remicade, from Johnson & Johnson.
Some analysts have forecast Orencia could eventually bring in $1 billion in revenue, while others have been more conservative. The drug is part of BMS’s five-year reorganization plan to focus on specialty treatments in areas of unmet need.
The approval, which follows an advisory committee’s unanimous recommendation in September, came as welcome news to BMS. In October the company encountered a setback when the FDA refused to approve its type 2 diabetes drug Pargluva (muraglitazar) without additional data on cardiovascular risk. An advisory panel had voted overwhelmingly to approve that drug, too.