Full Press Release Details
Corporate Statement Regarding Opzelura
WILMINGTON, Del. - November 2, 2021 - This morning,
as part of our Q3 2021 earnings call, we addressed a question related to samples and commercial supply of Opzelura (ruxolitinib)
As of today, we have received three product complaints related to texture.
As is standard with a product report of this kind, we are following all regulations and protocols including informing the U.S. Food and
Drug Administration, investigating the complaints and conducting a thorough root cause analysis across all batches to ensure continued
product quality and supply.
Early analytical testing of both the 5 gram and 60 gram batches of
Opzelura in question do not show any issues that would impact the safety or efficacy of the product. The texture issue is related to a
very small quantity of active product ingredient (API) not being completely dissolved, which has, on occasion, produced a slight gritty
In response to the product complaints, distribution of the affected
batches of product have been suspended.
At this time, we have no commercial supply issues. Sixty gram tubes
of Opzelura, which have passed release and 90-day quality control testing, remain available for distribution and additional batches of
product continue to be manufactured.
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
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: |
| o fever, sweating, or chills | o blood in your phlegm | o diarrhea or stomach pain |
| o muscle aches | o weight loss | o burning when you urinate or urinating more often than usual |
| o cough or shortness of breath | o warm, red, or painful skin or sores on your body | o 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:
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.
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.
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.
| Contacts: | |||
| Media | Investors | ||
| Catalina Loveman | +1 302 498 6171 cloveman@incyte.com | Christine Chiou | +1 302 274 4773 cchiou@incyte.com |
| Erica Cech | +1 302 274 4324 ecech@incyte.com |