The US Food and Drug Administration (FDA) has approved PharmaEssentia’s Besremi (ropeginterferon alfa-2b-njft) to treat adults with essential thrombocythaemia (ET).
This marks the first FDA-approved treatment for ET in nearly 30 years.
The approval is based on data from the global Phase III SURPASS ET trial, which demonstrated durable modified European Leukaemia Net (ELN) responses and sustained haematologic control in this patient group.
Besremi may be prescribed for adults with ET regardless of genotype or disease status, including those newly diagnosed and those who have not previously received cytoreductive therapy.
The regulatory decision in the US expands Besremi’s existing indication, adding to its previous authorisation for adults with polycythaemia vera (PV).
ET is a rare, chronic blood cancer characterised by platelet overproduction, and patients face a risk of serious complications, including heart attacks, strokes, and pulmonary embolism.
Besremi is described as a long-acting, interferon-based therapy intended to provide sustained disease management, with a mechanism designed to target disease-driving cells in the bone marrow while reducing elevated platelet counts.
The Phase III SURPASS ET trial compared Besremi with anagrelide and found superior durable response rates and a drop in thromboembolic events over 12 months of treatment.
PharmaEssentia founder and CEO Ko-Chung Lin said: “Today’s FDA approval of Besremi for ET is a significant advancement for patients and reflects PharmaEssentia’s longstanding commitment to advancing innovative therapies for people living with myeloproliferative neoplasms.
“We have been working closely with the FDA, healthcare providers, advocacy organisations and payers to bring this important treatment option to the ET community.”
The US approval follows recent regulatory decisions in Japan and Taiwan for Besremi in ET.
Headquartered in Taiwan with operations in China, Japan, Korea, and the US, PharmaEssentia retains global intellectual property rights for Besremi, which holds orphan drug designation in the US for both PV and ET.
