PharmaEssentia Gets US FDA's Approval for Essential Thrombocythemia Treament Drug; Shares Sink 10%

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PharmaEssentia (TPE:6446) has received approval from the US Food and Drug Administration for BESREMi (Ropeginterferon alfa-2b-njft) solution for injection in a pre-filled syringe of 500 mcg/mL and in a pre-filled pen injector 500 mcg/0.5 mL, according to a Friday filing to the Taiwan stock exchange.

The company's shares were down 10% in Monday's trade.

The drug is used in the treatment of adults with essential thrombocythemia and with polycythemia vera, or PV.

Following the approval, PharmaEssentia USA Corporation will start the sales and marketing activities of BESREMi (ropeginterferon alfa-2b) for essential thrombocythemia in the US.

The US FDA approved BESREMi (ropeginterferon alfa-2b-njft) for the treatment of all adults with PV in November 2021.

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