INCY - Incyte stock dips after FDA rejects approval of Jakafi's ER tablet form

2023-03-24 06:19:24 ET

The U.S. Food and Drug Administration (FDA) declined to approve Incyte's ( NASDAQ: INCY ) ruxolitinib extended-release (XR) tablets to treat certain types of myelofibrosis (MF), polycythemia vera (PV) and graft-versus-host disease (GVHD).

In its complete response letter (CRL), the FDA noted that it cannot approve the application in its present form.

The company said that the FDA acknowledged that the study submitted in the new drug application (NDA) met its goal of showing bioequivalence based on area under the curve (AUC) parameters but the agency recognized additional requirements for approval.

The NDA was backed by data from two trials to show that ruxolitinib XR tablets are dosage strength proportional and bioequivalent to Jakafi (ruxolitinib) tablets.

Incyte plans to meet with the FDA to decide 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," said Incyte CEO Hervé Hoppenot.

Jakafi — a JAK1/JAK2 inhibitor — is already approved in the U.S. to treat certain types of MF, PV and GVHD.

MF and PV are types of bone marrow cancer. GVHD is a potential complication of stem cell or bone marrow transplant in which the graft's (donor's) immune cells recognize the host as foreign and attack the recipient's body cells.

INCY -2.71% to $70.30 premarket March 24

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