The Food and Drug Administration (FDA) has approved Incyte drug Jakafi to treat Polycythemia Vera in patients who have had an unsatisfactory response to or do not tolerate hydroxyurea. This is the first time the FDA has approved a drug for PV.
Jakafi, a targeted kinase inhibitor manufactured by Incyte, reportedly offers a salutary option for some people affected by this serious blood disorder, a type of myeloproliferative disease.
“The approval of Jakafi represents an important advance for patients with uncontrolled PV. For the first time we are able to provide these patients a treatment that has been shown to provide effective and consistent control of their blood counts and reduce spleen volume,”
Srdan Verstovsek, Professorat the Texas University,Leukemia Department said.
Polycythemia Vera is a serious condition, characterized as a myeloproliferative neoplasm (MPN). The condition usually presents with elevated red blood cell counts, which in turn, can lead to a high viscosity of the blood and an increased risk of clotting. Additionally, elevated white blood cell and platelet counts may be present. Many patients also eventually develop a larger spleen, a condition which can be painful and even disfiguring.
PV is not an “active” condition, but this doesn’t mean it is not dangerous. Fortunately it can be easily detected with a simple blood test, examining a high hemoglobin level.
Occurring at virtually any age, it mostly affects elderly people, with a median age at diagnosis of 60 years. Moreover, approximately 50 out of every 100,000 patients in the United States are suffering from this malignant or premalignant disorder. Out of these 50 patients, about one-quarter of all patients will experience drug resistance to or intolerance for hydroxyurea.
The FDA initially approved ruxolitinib as a treatment for patients with intermediate and high-risk myelofibrosis back in November 2011. This approval meant its contributing to the treatment of primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis. In Myelofibrosis , Fibrosis occurs in bone marrow. It is a rare condition that replaces the ment of bone marrow by collagenous connective tissue fibres.
The most common side effects of Jakafi include: anemia, low platelet count, bruising, dizziness, headache.
