The US Food and Drug Administration (FDA) has approved and launched a new prefilled pen device for ropeginterferon alfa-2b-njft (BESREMi Pen) for adult patients with polycythemia vera, according to PharmaEssentia, the manufacturer.
The pen offers a more convenient self-administration option than the currently available prefilled syringe and is expected to become commercially available in the United States in the coming weeks, according to a press release by PharmaEssentia.
“The US approval of the BESREMi Pen™ is a significant milestone both for our company, as well as the patients we serve,” said Samuel Lin, Head of Global Operations at PharmaEssentia. “With this new device, we’re empowering more people living with PV to manage their condition with greater ease and confidence. It reflects our continued commitment to delivering not only innovative therapeutics, but also smarter, more intuitive ways to support long-term care.”
In June, the company announced that the Taiwan Ministry of Health and Welfare granted the drug its first global approval in a different indication: adult patients with essential thrombocythemia.
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