Back to top

Image: Bigstock

Incyte (INCY) Gets FDA Nod for Label Expansion of Opzelura

Read MoreHide Full Article

Incyte (INCY - Free Report) recently announced that the FDA has approved Opzelura (ruxolitinib) cream for another indication.

The regulatory body approved Opzelura cream 1.5% for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.

Vitiligo is a chronic autoimmune disease characterized by depigmentation of the skin. Opzelura is a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib.

The FDA approval was based on data from the phase III TRuE-V clinical trial program (TRuE-V1 and TRuE-V2), which evaluated the safety and efficacy of Opzelura versus vehicle in more than 600 people with nonsegmental vitiligo, aged 12 and older. 

The results showed that treatment with Opzelura resulted in significant improvements in VASI scores, which represent improvements in facial and total body repigmentation at week 24 (primary analysis) compared to vehicle (non-medicated cream) and in an open-label extension at week 52.

Per the company, Opzelura is the first and only FDA-approved product for repigmentation in nonsegmental vitiligo.

Please note that Opzelura was approved by the FDA in September 2021 for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.

In October 2021, Incyte’s Marketing Authorization Application (MAA) for ruxolitinib cream was validated by the regulatory body in Europe as a potential treatment for adolescents and adults (age >12 years) with nonsegmental vitiligo with facial involvement.

Shares have gained 9.3% year to date against the industry’s decline of 22.3%.


Zacks Investment Research
Image Source: Zacks Investment Research

Incyte’s lead drug Jakafi has been performing well, and its label expansion in additional indications is anticipated to further drive sales.  Sales of the drug came in at $544 million in the first quarter, up 17% year over year.

Jakafi is marketed by Incyte in the United States and by Novartis (NVS - Free Report) as Jakavi (ruxolitinib) outside the United States.

Incyte also earns product royalty revenues from Novartis for the commercialization of Jakafi in ex-U.S. markets.

Incyte’s pipeline is highly encouraging, and approval of new drugs diversifies the company’s pipeline.

However, pipeline setbacks and increased competition for Jakafi are concerns. The company is highly dependent on its lead drug Jakafi for a major chunk of its revenues, and a slowdown will adversely impact sales.

Incyte currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks are Alkermes (ALKS - Free Report) and Sarepta (SRPT - Free Report) . While Alkermes sports a Zacks Rank #1 (Strong Buy), Sarepta has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

ALKS’ loss estimates for 2022 have narrowed to 3 cents from a loss of 14 cents in the past 60 days. Alkermes surpassed earnings in all the trailing four quarters, the average being 350.48%.

Sarepta’s loss per share estimates for 2022 have narrowed by 61 cents in the past 90 days. SRPT’s earnings have surpassed expectations in all of the trailing four quarters, the average surprise being 21.45%.


In-Depth Zacks Research for the Tickers Above

Normally $25 each - click below to receive one report FREE:

Novartis AG (NVS) - free report >>

Alkermes plc (ALKS) - free report >>

Incyte Corporation (INCY) - free report >>

Sarepta Therapeutics, Inc. (SRPT) - free report >>

Published in