NEW YORK, NY, USA I September 19, 2023 I Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has granted marketing authorization for LITFULO™ (ritlecitinib) to treat adults and adolescents 12 years of age and older with severe alopecia areata. LITFULO, a once-daily oral capsule, is the first medicine authorized by the EC to treat individuals as young as 12 years of age with severe alopecia areata. LITFULO is also the first and only treatment to selectively inhibit Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) family of kinases.
“Today’s approval of LITFULO in Europe is an important milestone for patients as young as 12 years of age with substantial hair loss from alopecia areata, as they now have an opportunity 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 for adolescents with severe alopecia areata, and Pfizer is proud to be bringing forward this new innovative medicine for patients living with the challenges brought by this autoimmune disease.”
The marketing authorization for LITFULO is valid in all 27 EU member states, and in Iceland, Liechtenstein, and Norway. This authorization follows the recommendation for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in July 2023. It also follows approvals by the U.S. Food and Drug Administration (FDA) and the Japanese Ministry of Health, Labour and 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 and older with alopecia areata with 50% or more scalp hair loss, including patients with alopecia totalis (total scalp hair loss) and alopecia universalis (total body hair loss). Results from this pivotal study showed that 13.4% of adults and adolescents saw 90% or more 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 and was a key secondary outcome supporting the approval. At week 24, 49.2% of participants reported 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 and efficacy data being collected for adults with alopecia areata with 25% or greater scalp hair loss and adolescents from 12 years of age with alopecia areata with 50% or greater scalp hair loss. Long-term efficacy and safety data from this study were included in the submission to support the approval.
The most common adverse reactions reported with LITFULO included diarrhea (9.2%), acne (6.2%), upper respiratory tract infections (6.2%), urticaria (4.6%), rash (3.8%), folliculitis (3.1%), and dizziness (2.3%).
About Alopecia Areata
Alopecia areata is an autoimmune disease characterized by patchy or complete hair loss on the scalp, face, or body.1,2 The disease has an underlying immuno-inflammatory pathogenesis and 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, or ethnicity and can cause considerable burden beyond hair loss.1,2,3,4
About LITFULO™ (Ritlecitinib)
LITFULO is a first-of-its-kind treatment which irreversibly and selectively inhibits JAK3 and the TEC family of kinases by blocking γ-common cytokine signaling and reducing cytolytic activity of NK and 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 evaluated for potential additional indications. The Tranquillo Phase 3 study (NCT05583526) is investigating the efficacy, safety, and tolerability of ritlecitinib in adults and adolescents with non-segmental vitiligo.
US INDICATION
LITFULO is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older.
Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
1 Pratt CH, King LE Jr, Messenger AG, Christiano AM, Sundberg JP. Alopecia areata. Nat Rev Dis Primers. 2017;3:17011.
2 Islam N, Leung PSC, Huntley AC, et al. The autoimmune basis of alopecia areata: a comprehensive review. Autoimmun Rev. 2015:14(2):81-89.
3 Food and Drug Administration. The voice of the patient: a series of reports from the U.S. Food and Drug Administration’s (FDA’s) patient-focused drug development initiative. Silver Spring, MD:FDA;2018. Available from: https://www.fda.gov/files/about%20fda/published/Alopecia-Areata–The-Voice-of-the-Patient.pdf. Accessed 14 Dec. 2022.
4 Stefanaki C, Kontochristopoulos G, Hatzidimitrakib E, et al. A Retrospective Study on Alopecia Areata in Children: Clinical Characteristics and Treatment Choices. Skin Appen Dis. 2021; 7(6): 454–459.
SOURCE: Pfizer
Post Views: 128
NEW YORK, NY, USA I September 19, 2023 I Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has granted marketing authorization for LITFULO™ (ritlecitinib) to treat adults and adolescents 12 years of age and older with severe alopecia areata. LITFULO, a once-daily oral capsule, is the first medicine authorized by the EC to treat individuals as young as 12 years of age with severe alopecia areata. LITFULO is also the first and only treatment to selectively inhibit Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) family of kinases.
“Today’s approval of LITFULO in Europe is an important milestone for patients as young as 12 years of age with substantial hair loss from alopecia areata, as they now have an opportunity 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 for adolescents with severe alopecia areata, and Pfizer is proud to be bringing forward this new innovative medicine for patients living with the challenges brought by this autoimmune disease.”
The marketing authorization for LITFULO is valid in all 27 EU member states, and in Iceland, Liechtenstein, and Norway. This authorization follows the recommendation for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in July 2023. It also follows approvals by the U.S. Food and Drug Administration (FDA) and the Japanese Ministry of Health, Labour and 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 and older with alopecia areata with 50% or more scalp hair loss, including patients with alopecia totalis (total scalp hair loss) and alopecia universalis (total body hair loss). Results from this pivotal study showed that 13.4% of adults and adolescents saw 90% or more 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 and was a key secondary outcome supporting the approval. At week 24, 49.2% of participants reported 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 and efficacy data being collected for adults with alopecia areata with 25% or greater scalp hair loss and adolescents from 12 years of age with alopecia areata with 50% or greater scalp hair loss. Long-term efficacy and safety data from this study were included in the submission to support the approval.
The most common adverse reactions reported with LITFULO included diarrhea (9.2%), acne (6.2%), upper respiratory tract infections (6.2%), urticaria (4.6%), rash (3.8%), folliculitis (3.1%), and dizziness (2.3%).
About Alopecia Areata
Alopecia areata is an autoimmune disease characterized by patchy or complete hair loss on the scalp, face, or body.1,2 The disease has an underlying immuno-inflammatory pathogenesis and 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, or ethnicity and can cause considerable burden beyond hair loss.1,2,3,4
About LITFULO™ (Ritlecitinib)
LITFULO is a first-of-its-kind treatment which irreversibly and selectively inhibits JAK3 and the TEC family of kinases by blocking γ-common cytokine signaling and reducing cytolytic activity of NK and 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 evaluated for potential additional indications. The Tranquillo Phase 3 study (NCT05583526) is investigating the efficacy, safety, and tolerability of ritlecitinib in adults and adolescents with non-segmental vitiligo.
US INDICATION
LITFULO is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older.
Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
1 Pratt CH, King LE Jr, Messenger AG, Christiano AM, Sundberg JP. Alopecia areata. Nat Rev Dis Primers. 2017;3:17011.
2 Islam N, Leung PSC, Huntley AC, et al. The autoimmune basis of alopecia areata: a comprehensive review. Autoimmun Rev. 2015:14(2):81-89.
3 Food and Drug Administration. The voice of the patient: a series of reports from the U.S. Food and Drug Administration’s (FDA’s) patient-focused drug development initiative. Silver Spring, MD:FDA;2018. Available from: https://www.fda.gov/files/about%20fda/published/Alopecia-Areata–The-Voice-of-the-Patient.pdf. Accessed 14 Dec. 2022.
4 Stefanaki C, Kontochristopoulos G, Hatzidimitrakib E, et al. A Retrospective Study on Alopecia Areata in Children: Clinical Characteristics and Treatment Choices. Skin Appen Dis. 2021; 7(6): 454–459.
SOURCE: Pfizer
Post Views: 128
