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INCY > SEC Filings for INCY > Form 8-K on 18-Mar-2013All Recent SEC Filings

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Form 8-K for INCYTE CORP


18-Mar-2013

Other Events


Item 8.01 Other Events.

Incyte Corporation (the "Company") was informed last week of a case of progressive multifocal leukoencephalopathy ("PML") in a 75 year old male patient from the United Kingdom with myelofibrosis treated with ruxolitinib. Ruxolitinib is marketed by the Company as JakafiŽ in the United States and by Novartis as JakaviŽ outside the United States. It has not been determined whether development of PML in this case was related to the use of ruxolitinib. An independent assessment to confirm the diagnosis and evaluate the causality assessment provided by the investigator is planned. This is the only known case of PML in the approximately 9,800 myelofibrosis patients treated with ruxolitinib worldwide in clinical trials or with commercial product. Jakafi is approved in the United States for the treatment of patients with intermediate or high-risk myelofibrosis ("MF"), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF. The Company has informed the U.S. Food and Drug Administration of this case and, as part of its standard procedure for sharing available information in a timely manner, is in the process of informing investigators in its clinical trials. There are reports in the medical literature that suggest that patients with myeloproliferative neoplasms, including myelofibrosis, may be at higher risk of developing PML.


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