Bristol Myers Squibb ( BMY Quick Quote BMY - Free Report) announced that the FDA accepted the new drug application (NDA) and the European Medicines Agency (EMA) validated the marketing authorization application (MAA) for the pipeline candidate deucravacitinib, an oral, selective tyrosine kinase 2 (TYK2) inhibitor.
The applications are seeking approval for the candidate to treat adults with moderate-to-severe plaque psoriasis.
The FDA assigned a target action date of Sep 10, 2022. The European Medicines Agency’s validation confirms that the submission is complete and the regulatory body begins its centralized review process.
The regulatory applications are based on positive results from the POETYK PSO-1 and POETYK PSO-2 studies, which evaluated once-daily deucravacitinib in patients with moderate-to-severe plaque psoriasis versus placebo and
Amgen’s ( AMGN Quick Quote AMGN - Free Report) Otezla (apremilast). Deucravacitinib demonstrated significant and clinically meaningful improvements in skin clearance, symptom burden and quality-of-life measures compared to placebo and Otezla.
We note that the regulatory filing for deucravacitinib in Japan was already accepted for the treatment of adults with moderate-to-severe plaque psoriasis, pustular psoriasis and erythrodermic psoriasis.
We remind investors that Bristol Myers had to sell Otezla to Amgen when it acquired Celgene following concerns about a possible overlap expressed by the U.S. Federal Trade Commission.
Shares of the company have lost 12% year to date compared with the
industry's decline of 15.8%. Image Source: Zacks Investment Research
Deucravacitinib is currently being evaluated for multiple immune-mediated diseases, including psoriasis, psoriatic arthritis, lupus and inflammatory bowel disease. In addition to POETYK PSO-1 and POETYK PSO-2 studies, Bristol Myers is evaluating deucravacitinib in three other phase III studies on psoriasis.
Last month, Bristol Myers announced that the mid-stage study investigating deucravacitinib for the treatment of moderate-to-severe ulcerative colitis (UC) failed.
Bristol-Myers is looking to counter the generic threat and competition to its key drugs through new drug approvals and diversification of the top line. The plaque psoriasis has huge potential but competition is stiff in this market from the likes of
Novartis’ ( NVS Quick Quote NVS - Free Report) Cosentyx and AbbVie’s ( ABBV Quick Quote ABBV - Free Report) Skyrizi among others.
The FDA approved AbbVie’s Skyrizi (risankizumab-rzaa), an interleukin-23 (IL-23) inhibitor, for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Novartis’ Cosentyx has performed exceptionally well since its approval on continued label expansions and is one of the top revenue generators for NVS.
Bristol-Myers’ performance in the third quarter was encouraging as its key drugs Revlimid and Eliquis maintained a positive momentum throughout. Immuno-oncology drug Opdivo’s sales were also up after a slowdown earlier in the year.
BMY also obtained the FDA approval for Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed CAR T cell therapy for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL), at the start of this year.
Bristol-Myers also won the FDA approval for Abecma, a first-in-class B-cell maturation antigen (BCMA)-directed CAR T cell immunotherapy.
Bristol Myers currently carries a Zacks Rank #3 (Hold). You can see
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