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Incyte Announces U.S. FDA Approval of Opzelura™ (ruxolitinib) Cream, a Topical JAK Inhibitor, for the Treatment of Atopic Dermatitis (AD)

September 21, 2021 Off By BusinessWire

– Opzelura is the first and only topical Janus kinase (JAK) inhibitor approved in the United States

– In Phase 3 studies, Opzelura significantly reduced the skin inflammation and itch associated with AD

– Investor conference call and webcast scheduled for September 22, 2021, at 8:00 a.m. ET

WILMINGTON, Del.–(BUSINESS WIRE)–Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Opzelura™ (ruxolitinib) cream for the 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. Opzelura is the first and only topical formulation of a JAK inhibitor approved in the United States. Research shows dysregulation of the JAK-STAT pathway contributes to key features of AD such as itch, inflammation and skin barrier dysfunction¹.

“Atopic dermatitis is a chronic immune-mediated disease that can be challenging to manage. Many patients do not respond well to existing treatments and have uncontrolled disease,” said Jonathan Silverberg, M.D., Ph.D., M.P.H., Associate Professor of Dermatology and Director of Clinical Research and Contact Dermatitis at The George Washington University School of Medicine and Health Sciences. “As a clinician, I am excited to have a non-steroidal topical cream like Opzelura.”

“The approval of Opzelura is an important advancement in the treatment of AD, and we are pleased to offer a novel topical treatment option that targets a pathway believed to be a source of inflammation,” said Hervé Hoppenot, Chief Executive Officer, Incyte. “At Incyte, we are committed to transforming the treatment of immune-mediated dermatologic conditions like AD. We look forward to bringing Opzelura to the patient community and also continuing to explore its potential in other challenging skin diseases.”

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 3 studies (TRuE-AD1 and TRuE-AD 2) evaluating the safety and efficacy of Opzelura in more than 1,200 adolescents and adults with mild to moderate AD. Results from the studies showed patients experienced significantly clearer skin and itch reduction when treated with Opzelura cream 1.5% twice daily (BID), compared to vehicle (non-medicated cream):

Significantly more patients treated with Opzelura achieved Investigator’s Global Assessment (IGA) Treatment Success (IGA-TS, primary endpoint) at Week 8 (defined as an IGA score of 0 [clear] or 1 [almost clear] with at least a 2-point improvement from baseline): 53.8% in TRuE-AD1 and 51.3% in TRuE-AD2, compared to vehicle (15.1% in TRuE-AD1, 7.6% in TRuE-AD2; P<0.0001).

Significantly more patients treated with Opzelura experienced a clinically meaningful reduction in itch from baseline at Week 8, as measured by a ≥4-point reduction in the itch Numerical Rating Scale (itch NRS4): 52.2% in TRuE-AD1 and 50.7% in TRuE-AD2, compared to vehicle (15.4% in TRuE-AD1, 16.3% in TRuE-AD2; P<0.0001), among patients with an NRS score of at least 4 at baseline.

In clinical trials, the most common (≥1%) treatment-emergent adverse reactions in patients treated with Opzelura were nasopharyngitis, diarrhea, bronchitis, ear infection, eosinophil count increased, urticaria, folliculitis, tonsillitis and rhinorrhea². See Important Safety Information below, including Boxed Warnings for serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis, seen with JAK inhibitors for inflammatory conditions.

“It can be hard for people to fully appreciate how difficult AD can be and the tremendous impact it has on patients,” said Julie Block, President & CEO, National Eczema Association. “The chronic itch is difficult to cope with and related sleep issues can be exhausting. Many patients and their dermatologists are looking for additional options to meet current unmet needs in the management of AD. The approval of Opzelura is exciting news, and we welcome a new treatment option for our community.”

AD is a chronic skin disease affecting more than 21 million people aged 12 years and older in the U.S. and is characterized by inflammation and itch³. Signs and symptoms include irritated and itchy skin that can cause red lesions that may ooze and crust. People with AD are also more susceptible to bacterial, viral and fungal infections⁴.

Incyte is committed to supporting patients and removing barriers to access medicines. Eligible patients in the U.S. who are prescribed Opzelura have access to IncyteCARES (Connecting to Access, Reimbursement, Education and Support), a program offering patient support, including financial assistance and ongoing education and resources to eligible patients. For more information about IncyteCARES, please visit www.incytecares.com or call 1-855-452-5234, Monday through Friday, from 8 a.m. to 8 p.m. ET.

Conference Call Information

Incyte will host an analyst and investor conference call and webcast on September 22, 2021, at 8:00 a.m. ET. The live and archived webcast will be available via investor.incyte.com.

To access the conference call, please dial 877-407-3042 for domestic callers or +1-201-389-0864 for international callers (conference identification number 13723195).

If you are unable to participate, a replay will be available for 90 days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is +1-201-612-7415 (conference identification number 13723195).

About TRuE-AD

The TRuE-AD clinical trial program evaluating the safety and efficacy of ruxolitinib cream compared to vehicle (non-medicated cream) in patients with atopic dermatitis (AD) consists of two randomized, double-blind, vehicle-controlled Phase 3 studies: TRuE-AD1 (NCT03745638) and TRuE-AD2 (NCT03745651). Both studies enrolled more than 600 patients (age ≥12 years) who had been previously diagnosed with AD for at least two years and who were candidates for topical therapy.

Key findings from the TRuE-AD1 and TRuE-AD2 studies were presented at the European Academy of Dermatology and Venereology (EADV) Congress, Revolutionizing Atopic Dermatitis Virtual Symposium and previously announced by Incyte.

About Opzelura™ (ruxolitinib) Cream

Opzelura, a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, is the first and only topical JAK inhibitor approved for use in the United States 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. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended.

Additionally, ruxolitinib cream is in Phase 3 development for the treatment of adolescents and adults with vitiligo in the TRuE-V clinical program. Results from this Phase 3 program were recently announced.

Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura.

Opzelura is a trademark of Incyte.

IMPORTANT SAFETY INFORMATION

OPZELURA cream is for use on the skin only. Do not use OPZELURA cream in your eyes, mouth or vagina.

OPZELURA may cause serious side effects, including:

Serious Infections: OPZELURA cream contains ruxolitinib. Ruxolitinib belongs to a class of medicines called Janus kinase (JAK) inhibitors. JAK inhibitors are medicines that affect your immune system. JAK inhibitors can lower the ability of your immune system to fight infections. Some people have had serious infections while taking JAK inhibitors by mouth, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have been hospitalized or died from these infections. Some people have had serious infections of their lungs while taking OPZELURA. Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with OPZELURA.

OPZELURA should not be used in people with an active, serious infection, including localized infections. You should not start using OPZELURA if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster) while using OPZELURA.

Increased risk of death from all causes, including sudden cardiac death, has happened in people taking JAK inhibitors by mouth.

Cancer and immune system problems: OPZELURA may increase your risk of certain cancers by changing the way your immune system works. Some people have had lymphoma and other cancers while taking JAK inhibitors by mouth, especially if they are a current or past smoker. Some people have had skin cancers while taking OPZELURA. Your healthcare provider will regularly check your skin during your treatment with OPZELURA.

There is an increased risk of major cardiovascular events such as heart attack, stroke or cardiac death in people with cardiovascular risk factors and who are current or past smokers while using JAK inhibitors to treat inflammatory conditions.

Blood clots: Blood clots in the veins of your legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) can happen in some people taking OPZELURA. This may be life-threatening.

Low blood cell counts: OPZELURA may cause low platelet counts (thrombocytopenia), low red blood cell counts (anemia), and low white blood cell counts (neutropenia). If needed, your healthcare provider will do a blood test to check your blood cell counts during your treatment with OPZELURA and may stop your treatment if signs or symptoms of low blood cell counts happen.

Cholesterol increases: Cholesterol increase has happened in people when ruxolitinib is taken by mouth. Tell your healthcare provider if you have high cholesterol or triglycerides.

Before starting OPZELURA, tell your healthcare provider if you:

have an infection, are being treated for one, or have an infection that keeps coming back
have diabetes, chronic lung disease, HIV, or a weak immune system
have TB or have been in close contact with someone with TB
have had shingles (herpes zoster) or hepatitis B or C
live, have lived in, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections. These infections may happen or become more severe if you use OPZELURA. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common.
think you have an infection or have symptoms of an infection such as:

fever, sweating, or chills
muscle aches
cough or shortness of breath

blood in your phlegm
weight loss
warm, red, or painful skin or sores on your body

diarrhea or stomach pain
burning when you urinate or urinating more often than usual
feeling very tired

have ever had any type of cancer, or are a current or past smoker.
have had blood clots in the veins of your legs or lungs in the past.
have high cholesterol or triglycerides
have or have had low white or red blood cell counts
are pregnant or plan to become pregnant. It is not known if OPZELURA will harm your unborn baby. There is a pregnancy exposure registry for individuals who use OPZELURA during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. If you become exposed to OPZELURA during pregnancy, you and your healthcare provider should report exposure to Incyte Corporation at 1-855-463-3463.
are breastfeeding or plan to breastfeed. It is not known if OPZELURA passes into your breast milk. Do not breastfeed during treatment with OPZELURA and for about 4 weeks after the last dose.

After starting OPZELURA:

Call your healthcare provider right away if you have any symptoms of an infection. OPZELURA can make you more likely to get infections or make worse any infections that you have.
Get emergency help right away if you have any symptoms of a heart attack or stroke while using OPZELURA, including:
- discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
- severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
- pain or discomfort in your arms, back, neck, jaw, or stomach
- shortness of breath with or without chest discomfort
- breaking out in a cold sweat
- nausea or vomiting
- feeling lightheaded
- weakness in one part or on one side of your body
- slurred speech
Tell your healthcare provider right away if you have any signs and symptoms of blood clots during treatment with OPZELURA, including: swelling, pain or tenderness in one or both legs, sudden, unexplained chest or upper back pain, or shortness of breath or difficulty breathing.
Tell your healthcare provider right away if you develop or have worsening of any symptoms of low blood cell counts, such as: unusual bleeding, bruising, tiredness, shortness of breath or fever.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of OPZELURA include: pain or swelling in your nose or throat (nasopharyngitis), diarrhea, bronchitis, ear infection, increase in a type of white blood cell counts (eosinophil), hives, inflamed hair pores (folliculitis), swelling of the tonsils (tonsilitis), and runny nose (rhinorrhea).

These are not all of the possible side effects of OPZELURA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800-FDA-1088. You may also report side effects to Incyte Corporation at 1-855-463-3463.

About Incyte Dermatology

Incyte’s science-first approach and expertise in immunology has formed the foundation of the company. In Dermatology, the Company’s research and development efforts are focused on leveraging our knowledge of the JAK-STAT pathway to identify and develop topical and oral therapies with the potential to modulate immune pathways driving uncontrolled inflammation and help restore normal immune function.

Currently, Incyte is exploring the potential of JAK inhibition for a number of immune-mediated dermatologic conditions with a high unmet medical need, including vitiligo and hidradenitis suppurativa. To learn more, visit the Dermatology section of Incyte.com.

About Incyte

Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

Forward-Looking Statements

Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding whether or when Opzelura might provide a successful treatment option for patients with atopic dermatitis, the Company’s ongoing clinical development program for ruxolitinib cream and its dermatology program generally, contain predictions, estimates, and other forward-looking statements.

These forward-looking statements are based on the Company’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; the effects of the COVID-19 pandemic and measures to address the pandemic on the Company’s clinical trials, supply chain and other third-party providers and development and discovery operations; determinations made by the FDA or other regulatory authorities; the efficacy or safety of the Company’s products; the acceptance of the Company’s products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, including its annual report and its quarterly report on Form 10-Q for the quarter ended June 30, 2021. The Company disclaims any intent or obligation to update these forward-looking statements.

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¹ Bao L, et al. JAK-STAT. 2013;2(3):e24137. doi:10.4161/jkst.24137.

² Ruxolitinib cream Prescribing Information. Wilmington, DE. Incyte Corporation.

³ U.S. Census Bureau (2020). 2020 Decennial Census. Retrieved from https://data.census.gov/cedsci/table?q=Populations%20and%20People&tid=DECENNIALPL2020.P1 [data.census.gov].

⁴ Boguniewicz M, et al. Ann Allergy Asthma Immunol. 2018;120(1):10-22.