Bristol Myers' (BMY) Onureg Gets European Commission Approval

·3-min read

Bristol Myers Squibb BMY announced that the European Commission (EC) has granted full Marketing Authorization to Onureg (azacitidine tablets).

Onureg is authorized as a maintenance therapy in adult patients with acute myeloid leukemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed, hematopoietic stem cell transplantation (HSCT).

The approval was based on positive results from the QUAZAR AML-001 study, a phase III, international, randomized, double-blind study where Onureg significantly improved overall survival and relapse-free survival in patients with AML.

It is approved in the United States for continued treatment of adult patients with AML who achieved first CR or CR with incomplete blood count recovery following intensive induction chemotherapy and are not able to complete intensive curative therapy.

The approval of the drug in additional geographies will augment Bristol Myers’ strong oncology portfolio, which consists of drugs like Revlimid, Opdivo, Pomalyst, Sprycel and Yervoy, among others.

Bristol-Myers’ shares have gained 7.8% year to date against the industry's decline of 1.8%.

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The company’s performance in the first quarter of 2021 was dismal as its immuno-oncology drug Opdivo’s sales declined facing stiff competition from the likes of Merck’s MRK Keytruda. Moreover, Revlimid sales weren’t impressive.

Nevertheless, the recent approval of new drugs adds a stream of revenues, which should propel growth in the coming quarters.

In March, the company and partner bluebird bio, Inc. BLUE secured the FDA approval for Abecma (idecabtagenevicleucel; ide-cel) as the first B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma.

Last month, the FDA gave a nod to Zeposia (ozanimod) 0.92 mg for the treatment of adults with moderately-to-severely active ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD).

Bristol-Myers currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Repligen Corporation RGEN, which presently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Repligen’s earnings estimates for 2021 have increased to $2.26 from $1.91 in the past 60 days.

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