Shots:

• The approval is based on the (PEGINVERA) study to evaluate BESREMi in patients with Polycythemia Vera. BESREMi is manufactured by PharmaEssentia
• The results showed that patients treated with BESREMi achieved a CHR (61%) during the treatment period defined as hematocrit <45% & no phlebotomy in the preceding 2mos., platelets < 400 x 109/L and leukocytes < 10 x 109/L, normal spleen size assessed by ultrasound and absence of thromboembolic events, m-OS was ~20yrs.
• BESREMi was approved for risk of serious disorders including aggravation of neuropsychiatric, autoimmune, ischemic, and infectious disorders

Ref: Businesswire | Image: Onco360