Bristol Myers’ (BMY) sBLA for Orencia Gets FDA Priority Review


Bristol-Myers Squibb Company (BMY Quick QuoteBMY ) announced that the FDA has accepted its supplemental biologics license application (sBLA) for its marketed drug, Orencia (abatacept). The company is seeking an approval of the drug for the prevention of moderate to severe acute graft versus host disease (aGvHD) in patients aged six years and above who are receiving unrelated donor hematopoietic stem cell transplantation.

With the FDA granting a priority review to the sBLA, a decision from the regulatory body is expected on Dec 23, 2021.

The sBLA was based on data from the phase II ABA2 study as well as a registry study based on real-world evidence. Data from the same showed that treatment with Orencia led to a significant reduction in severe aGvHD and associated morbidity without an increase in disease relapse. The data from real-world analysis were similar to the data of the ABA2 study.

Shares of Bristol Myers have rallied 11.1% so far this year against the industry’s decrease of 2%.

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We remind investors that in December 2019, the FDA granted Breakthrough Therapy designation to Orencia for the prevention of moderate-to-severe aGvHD in hematopoietic stem cell transplants from unrelated donors.

Orencia is approved in the United States for the treatment of adult patients with moderately to severely active rheumatoid arthritis. It is also used for the treatment of adults with active psoriatic arthritis. Orencia is also indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis (pJIA) in patients aged two years and above.

In the first six months of 2021, Orencia generated sales worth $1.6 billion, reflecting an increase of 7% year over year. A potential label expansion of the drug for the aGvHD indication will boost sales for the company in the days ahead.

Zacks Rank & Stocks to Consider

Bristol Myers currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Spero Therapeutics, Inc. (SPRO Quick QuoteSPRO ) , Corvus Pharmaceuticals, Inc. (CRVS Quick QuoteCRVS ) and Vertex Pharmaceuticals Incorporated (VRTX Quick QuoteVRTX ) , all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Spero Therapeutics’ loss per share estimates have narrowed 9.1% for 2021 and 12.4% for 2022, over the past 60 days.

Corvus Pharmaceuticals’ loss per share estimates have narrowed 24.4% for 2021 and 21.4% for 2022, over the past 60 days.

Vertex’s earnings estimates have been revised 10.2% upward for 2021 and 6.4% upward for 2022 over the past 60 days.

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