The US Food and Drug Administration (FDA) recently updated Incyte Corporation (INCY - Analyst Report)’s sole marketed product Jakafi’s label. Jakafi is approved for the treatment of patients suffering from intermediate or high-risk myelofibrosis (MF) in the US. Jakafi is the first and only approved treatment for intermediate or high-risk myelofibrosis in the US.
A new recommended dosing guidance for patients suffering from low platelet count was included in the prescribing information for Jakafi along with additional safety information. According to the updated label, the recommended starting dose of the drug for MF patients having baseline platelet count between 50,000 to 100,000 is 5 mg (twice daily) along with the flexibility of subsequent dose modifications depending on safety and efficacy.
The US regulatory body updated the prescribing information for Incyte’s Jakafi after reviewing the supplemental New Drug Application (sNDA). Results from a phase II study (Study 258), on the above population were included in the sNDA application. The interim analysis of the above study revealed that the safety and efficacy data were consistent with the results observed in Incyte’s phase III program (COMFORT-I and COMFORT-II) on Jakafi.
We note that new safety information was also added to the Warnings and Precautions section of the prescribing information for Jakafi. The new information mentioned that in the event of progressive multifocal leukoencephalopathy (PML) being observed during treatment with Jakafi for MF, Jakafi treatment should be stopped.
Incyte is also looking to expand Jakafi’s label. It is also being studied for the treatment of polycythemia vera, essential thrombocythemia, solid/other hematologic tumors and pancreatic cancer.
Incyte, a biopharmaceutical company, currently carries a Zacks Rank #3 (Hold). Other biopharma stocks such as Jazz Pharmaceuticals Public Limited Company (JAZZ - Analyst Report), Santarus, Inc. and Cubist Pharmaceuticals Inc. (CBST - Analyst Report) currently look better positioned. While, Jazz Pharma and Santarus carry a Zacks Rank #1 (Strong Buy), Cubist Pharma carries a Zacks Rank #2 (Buy).