FDA approves Besremi for polycythemia vera.- PharmaEssentia Corp

The study showed that after 7.5 years of treatment with Besremi, 61% of patients with PV experienced a complete hematological response (defined as hematocrit less than 45% without phlebotomy for at least 2 months since last phlebotomy, platelets up to 400 x 109/L, leukocytes up to 10 x 109/L, normal spleen size (longitudinal diameter up to 12 cm for females and up to 13 cm for males). Importantly, 80% of patients achieved a hematological response (based on objective laboratory parameters only, with the exclusion of normal spleen size and thrombosis). These parameters are the most commonly used metrics to make therapeutic decisions.

In the pooled safety population of patients treated with Besremi, the most common adverse reactions (incidence >40%) were influenza-like illness, arthralgia, fatigue, pruritis, nasopharyngitis, and musculoskeletal pain. Serious adverse reactions (incidence > 4%) were urinary tract infection, transient ischemic attack and depression.