PharmaEssentia Resubmits Ropeginterferon alfa-2b-njft Application to the US FDA to Treat Polycythemia Vera (PV)

PharmaEssentia USA Corporation, a global biopharmaceutical innovator, leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced the resubmission of its Biologics License Application (BLA) to the US FDA, seeking approval for Ropeginterferon alfa-2b-njft for the treatment of Polycythemia Vera (PV), a rare blood cancer. Ropeginterferon alfa-2b-njft has an Orphan Drug designation for PV treatment in the United States.

Publish Date: 14-05-2021 Source: PharmaEssentia USA Corporation

Polycythemia vera (PV) is a chronic myeloproliferative neoplasm marked by an increase in morphologically normal red, white, and platelet cells, as well as erythrocytosis. Splenomegaly, microvascular events (such as transient ischemic attacks, erythromelalgia, and ocular migraine), and aquagenic pruritus are all common symptoms (itching triggered by exposure to hot water). Myelofibrosis and marrow failure affects 10% to 30% of patients, while acute leukemia affects 1.0 to 2.5 percent of diagnosed patients. Bleeding and arterial or venous thrombosis are more likely to occur. About 10% to 15% of patients eventually develop a syndrome similar to primary myelofibrosis but with a better prognosis.

The incidence of diagnosed Polycythemia vera (PV) cases is ~1.75 to 2.27 cases per 100,000 men and approximately 1.52 per 100,000 women in the USA.

However, the current Polycythemia vera (PV) treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (PTG-300, KRT-232, Idasanutlin, Ropeginterferon alfa-2b ) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK.) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for Polycythemia vera (PV) treatment. The key companies in to advance stage of results are Roche, PharmaEssentia, Kartos Therapeutics, Protagonist Therapeutics, AOP Orphan Pharmaceutical, Novartis & Incyte Corporation, etc.. targeting PV. Looking at the current clinical development and assets progress card, fast development and robust product would bring a game-changing opportunity for the pharmaceutical company developing products around the treatment of PV.

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Polycythemia vera (PV) to provide a clear understanding of the disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2021 to 2032.

About Thelansis:

Thelansis specializes in pharmaceutical market outlook and market forecast reports. We published reports across the therapeutic area, including rare / ultra-rare and mainstream indications. Over the period, we have built a robust repository of 6,000+ Bio-pharma reports that cover Epidemiology studies and Market forecasting based on the KOL opinions.

Competitive intelligence and track of trial results throughout the phases of development executed by a team of a mix of Scientific and Business backgrounds. As an organization, the primary focus is to provide real-world data evidence and market insight to pharmaceutical companies for their decision-making.