FDA Issues Complete Response Letter for Ruxolitinib Extended-Release Tablets

Credit: FDA.
The letter states that the application cannot be approved in its present form.

The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Incyte regarding the New Drug Application (NDA) for ruxolitinib extended-release (XR) tablets for once-daily use in the treatment of certain types of myelofibrosis, polycythemia vera, and graft-vs-host disease (GVHD).

According to the FDA letter, additional requirements will need to be met before a decision on approval can be made. The NDA submission included data from 2 studies that compared ruxolitinib XR tablets to ruxolitinib tablets.

Findings showed that the XR tablets were bioequivalent and dosage strength proportional to ruxolitinib tablets. Treatment with ruxolitinib XR 50mg tablets dosed once daily was found to be bioequivalent to ruxolitinib 25mg tablets dosed twice daily, based on area under the curve parameters.

“While we are disappointed that the FDA issued a Complete Response Letter for ruxolitinib extended-release tablets, we remain committed to advancing care for people with myeloproliferative neoplasms and GVHD,” said Hervé Hoppenot, CEO, Incyte. “We will work closely with the FDA on the appropriate next steps to address their comments.”

Ruxolitinib, a Janus kinase (JAK)1/JAK2 inhibitor, is currently marketed under the brand name Jakafi for the treatment of myelofibrosis, polycythemia vera, and GVHD. Jakafi is supplied in 5mg, 10mg, 15mg, 20mg, and 25mg tablets.


Incyte provides regulatory update on ruxolitinib extended-release tablets. News release. Incyte. Accessed March 27, 2023. https://www.businesswire.com/news/home/20230323005785/en/Incyte-Provides-Regulatory-Update-on-Ruxolitinib-Extended-Release-Tablets.