Bristol-Myers Squibb Company BMY announced that the FDA has approved Zeposia (ozanimod) for the treatment of adults with relapsing forms of multiple sclerosis (RMS) including those with clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.
Per the company, the once-daily oral medicine Zeposia (0.92 mg) becomes the only-approved sphingosine-1-phosphate (S1P) receptor modulator that offers RMS patients an initiation with no genetic test and requires no label-based first-dose observation for patients.
Notably, this is the first FDA-approved new drug application for Bristol-Myers following the acquisition of biotech giant Celgene Corporation last November. The combined company is well-positioned to address the needs of patients with cancer, inflammatory, immunologic, cardiovascular or fibrotic diseases through high-value innovative medicines and leading scientific capabilities.
Shares of Bristol-Myers have rallied 9.2% in the past year against the industry’s decline of 14.5%.
The FDA nod was based on data from the phase III SUNBEAM study and the pivotal RADIANCE Part B phase III study.
Both studies evaluated the efficacy, safety and tolerability of Zeposia against the weekly intramuscular Avonex (interferon beta-1a). While SUNBEAM investigated the same for a minimum 12-month treatment period, the other study evaluated the same for a regime of at least 24 months.
In both studies, Zeposia delivered powerful efficacy as measured by an annualized relapse rate (ARR) as well as in terms of the number and size of brain lesion compared with Avonex in the given patient population.
Zeposia is also under review in the EU for the treatment of adults with relapsing-remitting multiple sclerosis and a decision from the European Medicines Agency (EMA) is expected in the first half of 2020.
However, Bristol-Myers decided to delay the commercialization of Zeposia in the United States in the wake of the unprecedented COVID-19 pandemic, which ravaged the world of late.
The coronavirus pandemic, which claimed more than 23,000 lives globally, compelled healthcare systems to prioritize caring for the COVID-19 patients while restricting other activities. Along the same lines, earlier this week, Eli Lilly LLY announced that it is halting enrollment in most ongoing studies and also decides to delay any new study starts in order to allow doctors and healthcare facilities to focus solely on efforts for combating the coronavirus disease (COVID-19). Many others are expected to follow suit.
Zacks Rank & Other Stocks to Consider
Bristol-Myers currently carries a Zacks Rank #2 (Buy). Other stocks worth considering in the large cap pharma sector include Pfizer Inc. PFE and AbbVie Inc. ABBV, both sporting the same Zacks Rank as Bristol-Myers. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Pfizer’s earnings estimates have been revised 4.9% upward for 2020 over the past 60 days.
AbbVie’s earnings estimates have moved 2% north for 2020 over the past 60 days.
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