Bristol Myers Squibb and Merck & Co. must wait until the summer at least to learn the fate of Reblozyl’s potential label expansion into anemia from beta thalassemia, BMS said Friday.
The FDA has pushed back its decision on the drug, also known as luspatercept-aamt, by three months. The regulator now plans to issue a verdict on Reblozyl for anemia in adults with non-transfusion-dependent (NTD) beta thalassemia by June 27, Bristol said in a release.
As for the reason behind the delay, a “written response to an information request was determined by the FDA to constitute a major amendment,” BMS said. The regulator now needs extra time to fully review BMS’ submission, the company explained.
BMS didn’t specify what sort of information the FDA had requested.
Reblozyl is approved in the U.S. and the EU to treat transfusion-dependent anemia-associated beta thalassemia plus lower-risk myelodysplastic syndromes in patients who’ve failed an erythropoietin-stimulating agent and require red blood cell transfusions.
Reblozyl’s application in anemia with NTD beta thalassemia leverages safety and efficacy data from the pivotal phase 2 BEYOND study, which looked at the Merck/BMS drug alongside best supportive care in 145 adults with the disease. Regulators are reviewing a similar Reblozyl application in Europe, BMS said.
BMS is working on development and commercialization of Reblozyl with Merck following the New Jersey-based drugmaker’s $11.5 billion acquisition of Acceleron Pharma in November. Under the deal, BMS is on deck to pay low- to mid-20% royalties to Merck based on Reblozyl sales, Merck said last year.
Reblozyl forms a key part of BMS’ strategy to deliver at least $25 billion from new launches by 2029. The drug is part of a quartet of products that could reach peak sales of more than $4 billion alone or in combinations, BMS predicted earlier this year.
Aside from Reblozyl, BMS is banking on experimental offerings deucravacitinib—which has a September decision date with the FDA—and mavacamten, which is due for a ruling next month. The company is also counting on cancer newcomer relatlimab to pick up the slack once its blockbuster blood cancer drug Revlimid succumbs to generics later this year. Relatlimab was approved in March in a fixed-dose combination with BMS’ PD-1 inhibitor Opdivo in unresectable or metastatic melanoma. The combo therapy carries the moniker Opdualag.
Touted by BMS as a potential blockbuster drug during its Celgene buyout, Reblozyl has yet to break the billion-dollar threshold. BMS tallied $151 million in fourth quarter Reblozyl sales, with revenues for the med hitting $551 million for the year.