NEW YK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has granted marketing authization f LITFULO™ (ritlecitinib) to treat adults adolescents 12 years of age older with severe alopecia areata. LITFULO, a once-daily al capsule, is the first medicine authized by the EC to treat individuals as young as 12 years of age with severe alopecia areata. LITFULO is also the first only treatment to ively inhibit Janus kinase 3 (JAK3) the tyrosine kinase expressed in hepatocellular carcinoma (TEC) family of kinases.

“Today’s approval of LITFULO in Europe is an imptant milestone f patients as young as 12 years of age with substantial hair loss from alopecia areata, as they now have an opptunity to achieve significant hair regrowth,” said Angela Hwang, Chief Commercial Officer, President, Global Biopharmaceuticals Business, Pfizer. “Previously, there were no treatment options approved by the EC f adolescents with severe alopecia areata, Pfizer is proud to be bringing fward this new innovative medicine f patients living with the challenges brought by this autoimmune disease.”

The marketing authization f LITFULO is valid in all 27 EU member states, in Icel, Liechtenstein, Nway. This authization follows the recommendation f approval by the European Medicines Agency’s (EMA) Committee f Medicinal Products f Human Use (CHMP) in July 2023. It also follows approvals by the U.S. Food Drug Administration (FDA) the Japanese Ministry of Health, Labour Welfare (MHLW) in June 2023.

The approval was based on the ALLEGRO clinical trial program, which included the ALLEGRO Phase 2b/3 study (NCT03732807) that investigated LITFULO in patients 12 years of age older with alopecia areata with 50% me scalp hair loss, including patients with alopecia totalis (total scalp hair loss) alopecia universalis (total body hair loss). Results from this pivotal study showed that 13.4% of adults adolescents saw 90% me scalp hair coverage (SALT ≤10) after 24 weeks of treatment with LITFULO 50 mg compared to 1.5% with placebo. Patient Global Impression of Change (PGI-C) response was also measured was a key secondary outcome suppting the approval. At week 24, 49.2% of participants repted a response of “moderate” to “great” improvement in their alopecia areata compared to 9.2% with placebo.

ALLEGRO-LT (NCT04006457) is an ongoing Phase 3, open-label, long-term study, with safety efficacy data being collected f adults with alopecia areata with 25% greater scalp hair loss adolescents from 12 years of age with alopecia areata with 50% greater scalp hair loss. Long-term efficacy safety data from this study were included in the submission to suppt the approval.

The most common adverse reactions repted with LITFULO included diarrhea (9.2%), acne (6.2%), upper respiraty tract infections (6.2%), urticaria (4.6%), rash (3.8%), folliculitis (3.1%), dizziness (2.3%).

About Alopecia Areata

Alopecia areata is an autoimmune disease characterized by patchy complete hair loss on the scalp, face, body.1,2 The disease has an underlying immuno-inflammaty pathogenesis develops when the immune system attacks the body’s hair follicles, causing hair to fall out.1,2,3 Impacting approximately 2% of the population at some point during their lifetime, alopecia areata can affect people of any age, gender, race, ethnicity can cause considerable burden beyond hair loss.1,2,3,4

About LITFULO™ (Ritlecitinib)

LITFULO is a first-of-its-kind treatment which irreversibly ively inhibits JAK3 the TEC family of kinases by blocking γ-common cytokine signaling reducing cytolytic activity of NK CD8+ cells. This decreases the activity of parts of the immune system that are involved in the inflammation of hair follicles that causes hair loss in people with alopecia areata.

Ritlecitinib is also being uated f potential additional indications. The Tranquillo Phase 3 study (NCT05583526) is investigating the efficacy, safety, tolerability of ritlecitinib in adults adolescents with non-segmental vitiligo.

US INDICATION

LITFULO is a kinase inhibit indicated f the treatment of severe alopecia areata in adults adolescents 12 years older.

Limitations of Use: Not recommended f use in combination with other JAK inhibits, biologic immunomodulats, cyclospine other potent immunosuppressants.

US IMPTANT SAFETY INFMATION

LITFULO may cause serious side effects, including:

Serious infections. LITFULO can lower the ability of your immune system to fight infections. Do not start LITFULO if you have any kind of infection unless your healthcare provider tells you it is okay. Some people have had serious infections while taking LITFULO other similar medicines, including tuberculosis (TB), infections caused by bacteria, fungi, viruses that can spread throughout the body, have been hospitalized. Some people taking similar medicines to LITFULO have died from these infections. You may be at a higher risk of developing shingles (herpes zoster).

Your healthcare provider should test you f TB befe starting treatment with LITFULO should watch you closely f signs symptoms of TB during treatment with LITFULO.

Befe after starting LITFULO, tell your doct right away if you have an infection, are being treated f one, have symptoms of an infection, including:

  • fever, sweating, chills

  • muscle aches

  • cough shtness of breath

  • blood in your phlegm

  • weight loss

  • warm, red, painful skin ses on your body

  • diarrhea stomach pain

  • burning when you urinate urinating me often than usual

  • feeling very tired

LITFULO can make you me likely to get infections wsen infections you have. If you get a serious infection, your healthcare provider may stop treatment with LITFULO until your infection is controlled.

There is an increased risk of death in people 50 years older who have at least one heart disease (cardiovascular) risk fact are taking a Janus kinase (JAK) inhibit. LITFULO is a kinase inhibit.

Cancer immune system problems. LITFULO may increase your risk of certain cancers by changing the way your immune system wks. Lymphoma other cancers, including skin cancers, can happen. People, especially current past smokers, have a higher risk of certain cancers, including lymphoma lung cancers, while taking a JAK inhibit. Follow your healthcare provider’s advice about having your skin checked f skin cancer during treatment. Tell your healthcare provider if you have ever had any type of cancer.

There is an increased risk of maj cardiovascular events such as heart attack, stroke, death in people 50 years older who have at least one heart disease (cardiovascular) risk fact are taking a JAK inhibit, especially f current past smokers.

Get emergency help right away if you have any symptoms of a heart attack stroke while taking LITFULO, including:

  • discomft in the center of your chest that lasts f me than a few minutes, that goes away comes back

  • severe tightness, pain, pressure, heaviness in your chest, throat, neck, jaw

  • pain discomft in your arms, back, neck, jaw, stomach

  • shtness of breath with without chest discomft

  • breaking out in a cold sweat

  • nausea vomiting

  • feeling lightheaded

  • weakness in one part on one side of your body

  • slurred speech

Blood clots. Blood clots in the veins of your legs (deep vein thrombosis, DVT), lungs (pulmonary embolism, PE), eyes can happen in some people taking LITFULO. This may be life-threatening. Blood clots in the veins of the legs lungs have happened me often in people 50 years older, with at least one heart disease (cardiovascular) risk fact, taking a JAK inhibit. Tell your healthcare provider if you have had blood clots in the past.

Stop taking LITFULO get medical help right away if you have any signs symptoms of blood clots, including swelling, pain, tenderness in one both legs; sudden, unexplained chest upper back pain; shtness of breath difficulty breathing; changes in vision, especially in one eye only.

Allergic reactions. Symptoms that may mean you are having an allergic reaction have been seen during treatment with LITFULO. Some of these reactions were serious. Stop taking LITFULO get emergency medical help right away if you have symptoms of allergic reaction, including hives; rash; trouble breathing; feeling faint dizzy; swelling of your lips, tongue, throat.

Changes in certain labaty test results. Your healthcare provider should do blood tests befe you start taking LITFULO during treatment to check your lymphocyte, platelet counts, liver enzyme, creatine phosphokinase (CPK) levels. You should not take LITFULO if your lymphocyte counts platelet counts are too low your liver tests are too high. Increased CPK levels in the blood are common with LITFULO can also be severe. Your healthcare provider may stop treatment f a period of time if there are changes in these blood test results.

Do not take LITFULO if you are allergic to ritlecitinib any of the ingredients in LITFULO. See the Medication Guide f a complete list of ingredients.

Befe taking LITFULO, tell your healthcare provider if you:

  • have an infection, are being treated f one, have one that won’t go away keeps returning

  • have diabetes, chronic lung disease, HIV, a weak immune system

  • have TB have been in close contact with someone with TB

  • have had shingles (herpes zoster)

  • have had hepatitis B hepatitis C

  • live, have lived, traveled to certain areas (such as Ohio & Mississippi River Valleys the Southwest) where there is an increased chance f getting certain kinds of fungal infections. These infections may happen wsen when taking LITFULO. Ask your healthcare provider if you’re unsure if you have lived in an area where these infections are common

  • have had any type of cancer

  • have had blood clots

  • are a current past smoker

  • have had a heart attack, other heart problems, stroke

  • have liver problems

  • have abnmal blood tests (low platelet count white blood cell count)

  • have recently received are scheduled to receive any vaccinations. People who take LITFULO should not receive live vaccines right befe during treatment

  • are plan to become pregnant. It is not known if LITFULO will harm your unbn baby. Tell your healthcare provider if you are pregnant plan to become pregnant during treatment with LITFULO. There is a pregnancy registry f people who take LITFULO during pregnancy. Rept pregnancies to Pfizer, Inc. at 1-877-390-2940

  • are breastfeeding plan to breastfeed. It is not known if LITFULO passes into your breast milk. Do not breastfeed during treatment with LITFULO f 14 hours after your last dose of LITFULO. Talk to your healthcare provider about the best way to feed your baby during treatment with LITFULO

Tell your healthcare provider about all the medicines you take, including preion over-the-counter medicines, vitamins, herbal supplements. LITFULO other medicines may affect each other causing side effects.

The most common side effects of LITFULO include headache; diarrhea; acne; rash; hives; inflamed hair pes (folliculitis); fever; eczema; dizziness; shingles; decreased red blood cell counts; mouth ses, redness swelling of the lining of your mouth. These are not all of the possible side effects of LITFULO.