Incyte Corporation INCY announced that the FDA has extended the review period for its New Drug Application (NDA) for ruxolitinib cream. The NDA is seeking approval for ruxolitinib cream for the treatment of atopic dermatitis (AD).
The agency was scheduled to decide on the NDA on or by Jun 21, 2021. However, the Prescription Drug User Fee Act (PDUFA) action date has been extended by three months to Sep 21, 2021.
The FDA needs extra time to review additional analyses of previously submitted data provided by Incyte in response to the agency’s information request. The submission of the additional information has been determined by the FDA to constitute a major amendment to the NDA. Consequently, this has resulted in an extension of the PDUFA goal date.
Last week, the FDA also extended the review period for the supplemental New Drug Application (sNDA) for its lead drug, Jakafi (ruxolitinib), by three months. The sNDA is seeking the label expansion of the drug for the treatment of adult and pediatric patients aged 12 years and older with steroid-refractory chronic graft-versus-host disease (GVHD).
We note that Jakafi (ruxolitinib) is a first-in-class JAK1/JAK2 inhibitor approved by the FDA for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older. Jakafi is also indicated for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea as well as adults with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF.
Ruxolitinib cream is a proprietary formulation of ruxolitinib that has been designed for topical application. Ruxolitinib cream is currently in phase III development for the treatment of adolescents and adults with atopic dermatitis (TRuE-AD) and vitiligo (TRuE-V). Incyte has worldwide rights for the development and commercialization of ruxolitinib cream. Label expansion of the drug will further boost sales.
Shares of the company have lost 5.1% in the year so far against the industry’s 1.1% growth.
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Incyte’s performance in the first quarter was unimpressive, as Jakafi’s net sales were affected by typical seasonal effects and softer patient demand growth due to the ongoing pandemic. The company has a collaboration agreement with Novartis NVS.
Sanofi SNY and Regeneron’s REGN Dupixent (dupilumab) injection is approved to treat adults with moderate-to-severe eczema (atopic dermatitis). Dupixent is intended for patients whose eczema is not controlled adequately by topical therapies, or those for whom topical therapies are not advisable.
Incyte currently carries 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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