- The The FDA has issued a full response letter (CRL) to Incyte Corporation INCY Ruxolitinib prolonged-release tablets (XR), a JAK1/JAK2 inhibitor, for once-daily (QD) use in certain types of myelofibrosis (MF), polycythemia vera (PV), and graft-versus-host disease (GVHD).
- The full response letter states that the FDA cannot approve the application as it stands.
- The FDA acknowledged that the study submitted in the regulatory submission met its goal of bioequivalence based on area under the curve (AUC) parameters, but identified additional requirements for approval.
- Incyte intends to meet with the FDA to determine the appropriate next steps.
- William Blair writes that the CRL has no short-term implications from an immediate commercial perspective, nor does it impact Jakafi’s assumptions from the current loss of exclusivity in late 2028.
- The analyst writes that the QD formulation has additional patent protection beyond 2028, which may have helped extend the end of the franchise into the 2030s, and fixed-dose combinations (FDCs) are the key long-term sales driver.
- While probably not insurmountable, the CRL is a blow to the LIMBER program even more than that recent failure of the LIMBER-304 study.
- The BET and ALK2 programs still have a significant clinical trial runway, which hopefully will provide enough time to address the issues.
- Assuming changes to the prolonged-release formulation or additional clinical trials are required for QD approval of ruxolitinib. If so, it may delay potential work on FDCs needed to progress to pivotal trials.
- Price promotion: INCY shares are down 5.21% to $68.49 on the latest check Friday.
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