PharmaEssentia Corp. announced that it has submitted to the marketing authorization application of BESREMi (Ropeginterferon alfa-2b, P1101). Application submission/approval/disapproval/each of clinical trials(include interim analysis): The marketing authorization application of BESREMi (Ropeginterferon alfa-2b) 500mcg/mL and 250mcg/0.5mL solution for subcutaneous injection in prefilled syringe for PV has been submitted in Colombia.

Estimated date of completion: According to the review procedure of Colombian National Food and Drug Surveillance Institute (INVIMA). The actual review time and approval shall be subject to the decision of INVIMA. Polycythemia Vera (PV) is a chronic, progressive myeloproliferative neoplasm (MPN).

Although the overproduction of red blood cell is most dramatic, however, in most cases, there are elevated white blood cells and platelets as well. PV patients are at high risk of cardiovascular complications such as thrombosis and embolism and secondary myelofibrosis or leukemic transformation. According to the market research, there are more than 100,000 PV patients in Latin America, and the current treatment includes phlebotomy, hydroxyurea(HU), interferon and JAK2 inhibitors.