Benzinga -
- The FDA issued a complete response letter (CRL) to Incyte Corporation (NASDAQ: INCY) ruxolitinib extended-release (XR) tablets, a JAK1/JAK2 inhibitor, for once-daily (QD) use for certain types of myelofibrosis (MF), polycythemia vera (PV) and graft-versus-host disease (GVHD).
- The complete response letter states that the FDA cannot approve the application in its present form.
- The FDA acknowledged that the study submitted in the marketing application met its objective 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 from an immediate commercial perspective, the CRL has no near-term implications, nor does it impact Jakafi's assumptions through the current loss of exclusivity at the end of 2028.
- The analyst writes that the QD formulation does have additional patent protection beyond 2028, which could have helped extend the tail of the franchise into the 2030s, and fixed-dose combinations (FDCs) are the crucial long-term revenue driver.
- Though probably not insurmountable, the CRL is a blow to the LIMBER program, more so than the recent failure of the LIMBER-304 study.
- BET and ALK2 programs still have a significant clinical trial runway, hopefully providing sufficient time to address the issues.
- Suppose modifications are required to the extended-release formulation or additional clinical studies for QD ruxolitinib approval. In that case, it may delay the potential work on FDCs required to move into pivotal studies.
- Price Action: INCY shares are down 5.21% at $68.49 on the last check Friday.
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