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USFDA approves ropeginterferon alfa-2b-njft for rare blood disease
DTMT Network
The United States Foods and Drug Administration (FDA) has approved PharmaEssentia Corporation’s ropeginterferon alfa-2b-njft (Besremi) giving it an orphan drug designation for the treatment of ‘polycythemia vera’, a rare form of blood disease, that results in over-production of red blood cells.
The disease thickens the blood and patients develop the risk of clotting if untreated, an official statement released by FDA said.
Ann Farrell, director of the Division of Non-Malignant Hematology in the FDA’s Center for Drug Evaluation and Research said that “Polycythemia vera affects approximately 6,200 Americans each year.”
“This action highlights the FDA’s commitment to helping make new treatments available to patients with rare diseases,” she added.
Polycythemia vera usually is treated through management of symptoms like withdrawal of blood frequently, depending upon conditions, or using bone marrow suppressants.
Besremi is the first FDA-approved medication for polycythemia vera that patients can take regardless of their treatment history, and the first interferon therapy specifically approved for polycythemia vera, the statement added.
Patients can take injections of Besremi under the skin once every two weeks initially for one year, and if the drug is able to reduce the blood volume, its frequency can be reduced up to once every four weeks.
However, Besremi can result in increasing the level of liver enzyme levels, low levels of white blood cells, low levels of platelets, joint pain, fatigue, itching, upper airway infection, muscle pain and flu-like illness. Side effects may also include urinary tract infection, depression and stroke-like attacks, FDA cautioned.
It can risk fetal harm and patients should be tested for pregnancy before administering Besremi, it further warned.
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