The US Food and Drug Administration (FDA) has issued a complete response letter for ruxolitinib extended-release tablets, in which the regulatory agency stated that it could not approve the New Drug Application (NDA) for the therapy.
In the letter, the FDA stated the agency could not approve the application in its current form and identified additional requirements for approval, while acknowledging that the study submitted in the NDA met its objective of bioequivalence based on area under the curve (AUC) parameters.
Incyte, the manufacturer of the drug, intends to meet with the FDA to determine appropriate next steps.
The once-daily therapy is a treatment for certain types of myelofibrosis, polycythemia vera, and graft-versus-host disease.
The NDA application is based on two studies that aimed to show that ruxolitinib extended-release tablets are proportional in dosage strength and equivalent in bioavailability to ruxolitinib tablets. The first study compared the bioavailability of ruxolitinib extended-release tablets and ruxolitinib tablets, while also demonstrating that ruxolitinib extended-release tablets are proportional in dosage strength to ruxolitinib tablets.
The second study was a randomized, crossover study involving 63 healthy adults, which evaluated the bioequivalence of the highest strength of ruxolitinib extended-release tablets (50 mg) dosed once daily to the highest strength of ruxolitinib tablets (25 mg) dosed twice daily. The study found that extended-release ruxolitinib 50 mg tablets dosed once daily are bioequivalent to ruxolitinib 25 mg tablets dosed twice daily, based on AUC parameters.
Source: Incyte, March 2023