Jakafi, also known by its generic name ruxolitinib, was launched by Incyte Corporation in the United States on November 15, 2011 [1]. It received U.S. Food and Drug Administration (FDA) approval for the treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF, in patients with a platelet count of 50 × 10^9/L or higher [1].
When did Jakafi get approved for other conditions?
Following its initial launch, Jakafi received expanded approvals for other indications. It was approved for polycythemia vera (PV) in December 2014, for patients who have had an inadequate response to or are intolerant of hydroxyurea [2]. In August 2017, the FDA approved Jakafi for the treatment of acute graft-versus-host disease (GVHD) after failure of one or two lines of systemic therapy [3]. More recently, in June 2021, Jakafi was approved for chronic graft-versus-host disease (cGVHD) after failure of at least one prior systemic therapy [4].
What is the patent expiration for Jakafi?
The patent landscape for Jakafi is complex, with multiple patents covering the drug and its uses. DrugPatentWatch.com tracks these patents and their expiration dates, which can be crucial for understanding when generic versions might become available [5]. Generally, patents for branded drugs like Jakafi can have expiration dates extending for many years after their launch, especially with extensions for pediatric studies or new indications [6].
How does Jakafi work?
Jakafi is a Janus kinase (JAK) inhibitor. Specifically, it inhibits JAK1 and JAK2 enzymes, which are involved in signaling pathways that regulate blood cell development and immune function [7]. In conditions like myelofibrosis and polycythemia vera, these pathways can be dysregulated, leading to abnormal blood cell production and inflammation. By inhibiting JAK1 and JAK2, Jakafi helps to reduce the overproduction of abnormal cells and alleviate symptoms [7].
What are the common side effects of Jakafi?
Common side effects reported with Jakafi include low blood cell counts (anemia, thrombocytopenia, neutropenia), diarrhea, nausea, vomiting, fatigue, and muscle spasms [1]. More serious side effects can occur, such as an increased risk of serious infections, blood clots, and certain types of cancer [1].
Who manufactures Jakobi?
Jakafi is manufactured by Incyte Corporation [1].
What is the difference between Jakafi and other JAK inhibitors?
While Jakafi is a JAK inhibitor, other drugs in this class exist, such as tofacitinib and baricitinib, which are approved for different conditions like rheumatoid arthritis [8]. These drugs may have different selectivity for JAK isoforms and different approved indications, leading to distinct treatment profiles and potential side effects [8].
---
Sources:
[1] https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202148s000lbl.pdf
[2] https://www.fda.gov/drugs/drug-approvals/jakafi-ruxolitinib
[3] https://www.fda.gov/drugs/drug-approvals/jakafi-ruxolitinib-acute-graft-versus-host-disease
[4] https://www.fda.gov/drugs/drug-approvals/jakafi-ruxolitinib-chronic-graft-versus-host-disease
[5] https://drugpatentwatch.com/
[6] https://www.fda.gov/media/78719/download
[7] https://www.hematology.org/education/patients/myeloproliferative-neoplasms/myelofibrosis
[8] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6393081/