The Food and Drug Administration on Monday approved wider use of a drug important to Bristol Myers Squibb’s future, clearing the medicine for people newly diagnosed with a cancer-like disease of the bone marrow.
Called Reblozyl, the drug has been available in the U.S. since 2019, when the FDA gave it the OK to treat patients with anemia due to the blood disease beta thalassemia. Bristol Myers, which inherited the drug when it acquired Celgene that year, has since focused on broadening its use, projecting more than $4 billion in global Reblozyl sales by the end of the decade.
To get there, Bristol Myers tested Reblozyl earlier in treatment of the bone marrow condition, a group of diseases collectively called myelodysplastic syndromes.
Some estimates hold that about 10,000 people in the U.S. are diagnosed with MDS each year. The condition occurs when the bone marrow doesn’t make enough healthy blood cells, often triggering anemia and the need for medicines that can alleviate it. The disease can also progress to a form of leukemia.
U.S. regulators in 2020 approved Reblozyl for MDS, but only after older drugs stop working. It also limited availability to a subset of patients whose disease has specific characteristics.
Study results presented at the American Society of Clinical Oncology meeting in May showed that Reblozyl has broader benefits, however. A Phase 3 trial found that Reblozyl outperformed Epogen, a type of medicine that’s been used to treat anemia in MDS for decades. Specifically, patients at low risk of disease progression and who hadn’t previously been treated were less likely to need blood transfusions if they received Reblozyl.
That study formed the basis of Bristol Myers’ U.S. application. Notably, the FDA approved the drug in newly diagnosed patients regardless of the amount of “ring sideroblasts” they have at diagnosis. The majority of newly diagnosed MDS patients don’t have these types of immature cells, which have rings of iron around their nucleus. Reblozyl’s benefits in these RS-negative patients were less clear, a “point of debate” following the release of the data, wrote William Blair analyst Matt Phipps.
“This is clearly a positive for Bristol Myers and Reblozyl,” Phipps wrote in a Tuesday note to investors. “This approval was essential for the growth of the company’s new commercial portfolio, particularly in light of upcoming drug price negotiations,” he added, referencing the newly granted authority Medicare has to lower the price of certain prescription drugs.
Bristol Myers is among those impacted by the new law. The blood thinner Eliquis, which it sells along with Pfizer, was on the list of the initial 10 drugs subject to negotiation with Medicare.
Eliquis is also set to lose patent protection in the U.S. later this decade, as is Bristol Myers’ cancer drug Opdivo. The two drugs earned $20 billion in combined sales last year.
The company is hoping that Reblozyl, as well as the heart drug Camzyos, cancer immunotherapy Opdualag and autoimmune disease treatment Sotkytu, can help cover those losses.
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- Source: https://www.biopharmadive.com/news/bristol-myers-reblozyl-myelodysplastic-syndromes-fda-approval/692183/