FDA Rejects NDA for Extended-Release Jakafi

The FDA has issued a complete response letter for the new drug application (NDA) for Incyte’s Jakafi (ruxolitinib) extended-release tablets. The product was being reviewed for once-daily use to treat patients with certain types of myelofibrosis, polycythemia vera and graft-versus-host disease.

Regulatory officials said the data met the objective of bioequivalence parameters but identified additional requirements for approval. Incyte intends to meet with the FDA to determine appropriate next steps.

“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,” Hervé Hoppenot, chief executive officer of Incyte, said in a press relese. “We will work closely with the FDA on the appropriate next steps to address their comments.”

The NDA was based on two studies. The first study was designed to determine the relative bioavailability of the extended-release tablets to Jakafi and to demonstrate that that the extended-release tablets are dosage strength proportional to Jakafi. The second study was an open-label, two-way crossover study in 63 healthy adults evaluating the bioequivalence of the 50 mg tablet dosed once-daily to the 25 mg tablet dosed twice-daily.

Jakafi generated sales of $2.41 billion in 2022, an increase from 2021.