Incyte Gets CRL for Jakafi Extended-Release Tablets

Title: Incyte Receives Complete Response Letter for Jakafi Extended-Release Tablets


Incyte Corporation, a global biopharmaceutical company, has received a complete response letter (CRL) from the United States Food and Drug Administration (FDA) regarding their new drug application for Jakafi extended-release tablets. Jakafi is a widely used medication for the treatment of multiple myelofibrosis and polycythemia vera, two rare blood cancer conditions. In this blog post, we will explore the key points surrounding Incyte’s CRL and the potential impact on patients awaiting a new treatment option.

Key Points:

  1. Understanding Myelofibrosis and Polycythemia Vera:
    Myelofibrosis and polycythemia vera are rare blood cancers that cause overproduction of abnormal blood cells in the bone marrow, leading to symptoms such as fatigue, weakness, and an enlarged spleen. These conditions can cause anemia, blood clots, and life-threatening complications.
  2. Jakafi: A Leading Treatment for Blood Cancers:
    Jakafi (ruxolitinib) is an approved medication for the treatment of myelofibrosis and polycythemia vera. It works by inhibiting certain enzymes that contribute to the overproduction of blood cells and reducing symptoms associated with these conditions.
  3. Incyte’s New Drug Application:
    Incyte submitted a new drug application to the FDA for Jakafi’s extended-release tablets, which would provide a new and innovative dosing regimen for patients. The extended-release tablets aim to make treatment more convenient for patients, improving adherence, and potentially reducing side effects commonly associated with the medication.
  4. The Complete Response Letter:
    Incyte received a CRL from the FDA regarding their new drug application for Jakafi extended-release tablets, citing concerns regarding the drug’s efficacy and safety. The CRL means that the FDA will not approve the new medication until additional data is provided that addresses the concerns noted in the letter.
  5. The Potential Impact on Patients:
    The CRL for Jakafi extended-release tablets delays the availability of a potentially beneficial medication for patients living with myelofibrosis and polycythemia vera. The extended-release tablets offer an innovative dosing regimen, which would address some of the challenges of current therapies, such as the need for multiple daily doses.
  6. The Path Forward:
    Incyte will work with the FDA to address the concerns raised in the CRL and provide the necessary data to support the approval of Jakafi extended-release tablets. Incyte’s commitment to innovation and improving treatment options for patients living with rare blood cancers remains unwavering.


The complete response letter from the FDA regarding Jakafi extended-release tablets is a setback for patients awaiting new and innovative treatment options for myelofibrosis and polycythemia vera. Despite this setback, Incyte’s involvement in developing effective and patient-friendly treatment options is commendable. The company has remained steadfast in their efforts to address the needs of patients living with rare blood cancers, and the hope is that the necessary data will be provided to address the concerns raised in the CRL. As Incyte continues to work with regulatory agencies, healthcare providers, and patients, they remain committed to driving progress in the field of blood cancer treatment.