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Incyte (INCY) Ruxolitinib Cream Wins FDA Nod for Atopic Dermatitis

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Incyte (INCY - Free Report) recently announced that the FDA has approved the cream formulation of its selective JAK1/JAK2 inhibitor ruxolitinib for the treatment of mild to moderate atopic dermatitis (AD).

Ruxolitinib cream has been approved under the brand name Opzelura for the short-term and non-continuous chronic treatment of mild to moderate AD in non-immunocompromised patients 12 years of age and older. Their disease is not adequately controlled with topical prescription therapies, or those therapies are not advisable.

The approval makes Opzelura the first and only topical formulation of a JAK inhibitor approved in the United States.

AD is a chronic skin disease characterized by inflammation and itch.

The FDA approval was based on data from the TRuE-AD (Topical Ruxolitinib Evaluation in Atopic Dermatitis) clinical trial program consisting of two randomized, double-blind, vehicle-controlled phase III studies (TRuE-AD1 and TRuE-AD 2). The studies evaluated the safety and efficacy of Opzelura in more than 1,200 adolescents and adults with mild to moderate AD. Results from the studies showed that patients experienced significantly clearer skin and itch reduction when treated with Opzelura cream 1.5% twice daily (BID) compared to vehicle (non-medicated cream).

The approval will generate an incremental stream of revenues for Incyte and should cheer investors. The FDA had earlier extended the review period for Incyte’s new drug application (NDA) for ruxolitinib cream for the treatment of AD.

While the AD market has potential, competition is stiff. Sanofi (SNY - Free Report) and Regeneron’s (REGN - Free Report) Dupixent (dupilumab) injection is approved to treat adults with moderate-to-severe AD.

Shares of the company have lost 12.5% in the year so far compared with the industry’s 1.3% decline.

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Incyte’s lead drug Jakafi sales recorded growth in the second quarter after a soft first quarter. The uptake of Pemazyre is also gaining traction. The company’s efforts to diversify its revenue base are encouraging as well and approval of additional drugs will boost revenues.

Last month, Incyte and partner MorphoSys AG (MOR - Free Report) obtained the European Commission’s approval for tafasitamab under the brand name Minjuvi for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma.

However, the company has suffered a few setbacks of late. The FDA has issued a complete response letter (CRL) for the biologics license application (BLA) for its intravenous PD-1 inhibitor, retifanlimab, for the treatment of adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or are intolerant of platinum-based chemotherapy.

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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