Bristol-Myers Squibb Company (BMY Quick QuoteBMY - Free Report) announced that the European Commission has approved Orencia intravenous (IV) infusion and subcutaneous (SC) injection, in combination with methotrexate (MTX), for the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis (RA) not previously treated with MTX. This makes Orencia the first biologic therapy to gain an EU approval specifically for the treatment of MTX-naive RA patients with highly active and progressive disease.

The EU approval was largely expected as the Committee for Medicinal Products for Human Use had issued a favorable opinion this July.

We remind investors that both the IV and SC formulations of Orencia are already approved in the U.S. and the EU 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 RA. Orencia may be used as monotherapy or with disease-modifying, anti-rheumatic drugs other than tumor necrosis factor antagonists.

It is also approved for reducing signs and symptoms in pediatric patients aged six years and older, with moderately-to-severely active polyarticular juvenile idiopathic arthritis, and may be used as monotherapy or concomitantly with MTX.

We are encouraged by the recent label expansion of Orencia. In the first half of 2016, the product recorded global sales of $1.1 billion, reflecting a year-over-year increase of 24%. Growth was mainly driven by high demand for the product. The label expansion will allow Orencia access to an expanded patient population and increase the commercial potential of the product.

Bristol-Myers is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Anika Therapeutics Inc. (ANIK Quick QuoteANIK - Free Report) , Geron Corporation (GERN Quick QuoteGERN - Free Report) and Corcept Therapeutics Incorporated (CORT Quick QuoteCORT - Free Report) . All the three stocks sport a Zacks Rank #1 (Strong Buy).

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