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Bristol-Myers Gets FDA Nod for Orencia's Label Expansion

Bristol-Myers Squibb Company BMY announced that the FDA has approved Orencia for the treatment of adults with active psoriatic arthritis (PsA).

The approval was based on results from two randomized, double-blind, placebo-controlled trials. Per the data from the trials, Orencia improved (or reduced) disease activity in both TNF-naive and exposed patients suffering from increased disease activity, high tender and swollen jointsfor more than seven years.

Orencia is already indicated for adult patients with moderate to severe active rheumatoid arthritis (RA)as well as for reducing signs and symptoms in pediatric patients with moderately to severely active polyarticular juvenile idiopathic arthritis.

Sales of Orencia came in at $535 million in the first quarter of 2017, up from $475 million in the year-ago quarter. U.S. sales in the quarter were up 13% despite unfavorable inventory movement. However, demand was softer in the subcutaneous market in the beginning of the year due to early coverage resets.

A label expansion of the drug will further boost sales.

We note that in Sep 2016, Orencia became the first biologic therapy to gain EU approval specifically for the treatment of methotrexate (MTX)-naïve RA patients with highly active and progressive disease.

Competition is stiff in the psoriatic arthritis with the presence of drugs like AbbVie’s ABBV Humira and Novartis’ NVS Cosentyx.

While Bristol-Myers’ share price has declined 5.4% year to date, the Zacks classified Large Cap Pharmaceuticals industry has gained 10.7%.

Bristol-Myers’ key products – Opdivo, Orencia, Eliquis and Sprycel – should continue to fuel the company’s top line. Meanwhile, Bristol-Myers is working on expanding the label of Opdivo which should boost performance further. The EC recently approved Opdivo as a monotherapy for the treatment of SCCHN in adults. However, Opdivo is facing competitive challenges in the U.S. With the FDA approving Merck’s MRK Keytruda, for the first-line treatment of metastatic nonsquamous NSCLC, the company is expected to see further loss of market share.

Zacks Rank

Bristol-Myers currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank stocks here.

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