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With Phase III Success, PharmaEssentia To Seek Besremi Label Expansion (Update)

 
• By Joseph Haas

Taiwan-based PharmaEssentia hopes to add essential thrombocytopenia to the label for its pegylated interferon product, already approved to treat polycythemia vera.

PharmaEssentia wants to add a second platelet disorder to the Besremi label (Shutterstock)

UPDATE – PharmaEssentia has corrected the press release issued 6 January about the Phase III results for Besremi in essential thrombocytopenia to note the incidence of two treatment-related serious adverse events in the Besremi arm; the previous press release reported zero TRSAEs. Scrip has revised this article to include the new data and confirmed the company’s view that Besremi has a relatively better safety profile than anagrelide.

Taiwan-headquartered PharmaEssentia is advancing toward its goal of adding a second indication – essential thrombocytopenia – to the label for Besremi, its pegylated interferon product approved in 2021 for polycythemia vera

Key Takeaways
  • PharmaEssentia reported successful Phase III data for Besremi in essential thrombocytopenia, a disease with no new drugs approved in the US since 1997.
  • Besremi is approved to treat polycythemia vera; adding ET to the product label would nearly double the product’s addressable patient population

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