Yahoo Finance Incyte (INCY) Gets CRL for Jakafi Extended-Release Tablets
Incyte Corporation INCY announced that the FDA has issued a complete response letter (CRL) for the company’s new drug application (NDA) seeking approval for the extended-release (XR) tablet formulation of Jakafi (ruxolitinib) for the treatment of certain types of myelofibrosis (MF), polycythemia vera (PV) and graft-versus-host disease (GVHD).
Ruxolitinib is Incyte’s once-daily JAK1/JAK2 inhibitor.
In the past year, the shares of Incyte has lost 7.9% compared with the industry’s decline of 15.7%.
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The NDA submission by Incyte was based on data from two studies designed to show that ruxolitinib XR tablets are dosage strength proportional and bioequivalent to Jakafi tablets.
Per the FDA’s CRL, the NDA in its present form cannot be approved. Study data, submitted along with the NDA, showed that ruxolitinib met the bioequivalence objective of Incyte’s Jakafi (ruxolitinib) tablets based on the area under the curve parameters. However, the FDA identified other additional requirements that were not satisfied for the approval of ruxolitinib XR tablets. Following the issue, Incyte intends to work closely with the FDA to discuss steps going forward to address the FDA’s decision.
Jakafi, Incyte’s lead drug, is a first-in-class JAK1/JAK2 inhibitor, approved in the United States for the treatment of patients with PV, who have had an inadequate response to or are intolerant to hydroxyurea. It is also approved for the treatment of patients with intermediate or high-risk MF, including primary MF, post-PV MF and post-essential thrombocythemia MF. The drug is also approved in the United States for the treatment of steroid-refractory acute GVHD in adult and pediatric patients aged 12 years or older.
Jakafi sales came in at $2.4 billion in 2022, contributing 71% to total revenues. Incyte has a collaboration agreement with Swiss pharma giant Novartis NVS for Jakafi. Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi outside the country.
However, Incyte faces competition from other players in the market like Bristol-Myers Squibb Company BMY and CTI BioPharma Corp. CTIC. Bristol-Myers’ Inrebic (fedratinib) is approved for the treatment of adult patients for three indications – intermediate-2 or high-risk primary MF, post-PV MF and post-essential thrombocythaemia MF. Bristol-Myers also received marketing authorization in the European Union from the European Medicine Agency in early 2021 for the same three indications as in the United States.
CTI Biopharma got accelerated approval for pacritinib in February 2022 for the treatment of adults with intermediate or high-risk primary or secondary (post-PV or post-essential thrombocythemia) MF with a platelet count below 50 × 109 /L (1). CTI markets pacritinib, under the brand name Vonjo in the United States. CTI plans to complete its confirmatory PACIFICA study reporting top-line results in mid-2025.
Incyte Corporation Price and Consensus
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Zacks Rank
Incyte currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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