Incyte Gets CRL for Jakafi Extended-Release Tablets

The FDA has told Incyte that it can’t review the company’s new drug application (NDA) for Janus kinase inhibitor Jakafi (ruxolitinib) extended-release (XR) tablets without more supporting data.

In a Complete Response Letter to the company, the agency acknowledged that Incyte’s bioequivalence study met its objective but said the company needs to satisfy other requirements for approval. The company did not divulge what those were.

Ruxolitinib is a once-daily treatment for certain types of myelofibrosis, polycythemia vera and graft-versus-host disease.

Incyte said it intends to meet with the FDA to determine the next steps for the NDA.

Incyte

Incyte is an American multinational pharmaceutical company with headquarters in Wilmington, Delaware, and Morges, Switzerland. The company was created in 2002 through the merger of Incyte Pharmaceuticals, founded in Palo Alto, California in 1991 and Incyte Genomics, Inc. of Delaware. The company currently operates manufacturing and R&D locations in North America, Europe, and Asia.

Incyte Corporation currently develops and manufacturers prescription biopharmaceutical medications in multiple therapeutic areas including oncology, inflammation, and autoimmunity.