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Incyte's (INCY) sNDA Review for Jakafi in GVHD Gets Extended

Incyte INCY announced that the FDA has extended the review period for the supplemental New Drug Application (sNDA) for lead drug, Jakafi (ruxolitinib).

The sNDA is seeking the label expansion of the drug for the treatment of adult and pediatric patients 12 years and older with steroid-refractory chronic graft-versus-host disease (GVHD).

The new Prescription Drug User Fee Act (PDUFA) target action date is Sep 22, 2021. The agency was earlier set to decide on the sNDA on Jun 22, 2021. The FDA extended the target action date for reviewing additional data submitted 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 sNDA. Hence, this has resulted in an extension of the PDUFA goal date by three months.

The sNDA was based on data from REACH3, a phase III randomized, open-label, multicenter study, which compared Jakafi with best available therapy (BAT) in adult and pediatric patients 12 years and older with steroid-refractory chronic GVHD.

We note that Jakafi 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.

An additional label expansion of the drug will boost sales.  

Shares of the company have lost 2.6% in the year so far compared with the industry’s 1.6% decline.

 

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Incyte’s performance in the first quarter was unimpressive, as lead drug 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.

The NDA seeking approval of ruxolitinib cream for the treatment of atopic dermatitis (AD) has been accepted for Priority Review by the FDA and the PDUFA date has been set for Jun 21, 2021.

AbbVie ABBV and Johnson & Johnson’s JNJ Imbruvica is approved for the treatment of adult patients with chronic GVHD.

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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