Bristol Myers' Expanded Approval For Anemia Drug, Shows Superior Efficacy Over Concurrent Blood Transfusion

On Monday, the FDA approved Bristol Myers Squibb Co's BMY Reblozyl (luspatercept-aamt) for anemia without previous erythropoiesis-stimulating agent use (ESA-naïve) in adult patients with very low-to-intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell transfusions. 

This expanded indication to the first-line setting is based on interim results from the pivotal Phase 3 COMMANDS trial, in which Reblozyl demonstrated superior efficacy of concurrent RBC transfusion independence and hemoglobin increase compared to epoetin alfa, an ESA, regardless of ring sideroblast status. 

William Blair analyst Matt Phipps notes that the efficacy results included in the label do not break out responses by RS status and specifically state."

Considering the imminent discussions surrounding drug pricing negotiations, this comes at a particularly opportune juncture.

The analyst says that development bodes well for Bristol Myers and their product Reblozyl, as a significant majority - more than two-thirds - of recently diagnosed MDS patients are anticipated to be RS negative. 

Nevertheless, William Blair says that while the patient population distribution might not be as heavily skewed, this approval holds substantial importance. 

Projections indicate an impressive non-risk-adjusted peak sales forecast surpassing $4 billion for Reblozyl. This regulatory approval emerges as a pivotal factor fueling the company's fresh commercial portfolio expansion. 

Price Action: BMY shares are up 1.60% at $62.63 on the last check Tuesday.