First drug of its class to be approved in Singapore for severe alopecia areata in patients as young as 12.1
Litfulo has been approved by the Health Sciences Authority (HSA) in Singapore and is now available from 1st December 2024.
SINGAPORE, 1st December 2024 – Pfizer Singapore today announced that the Health Sciences Authority has approved LITFULO™ (ritlecitinib), a once-daily oral treatment, for individuals 12 years of age and older with severe alopecia areata.2 It is a kinase inhibitor that inhibits Janus kinase 3 (JAK3) and the tyrosine kinase expressed in the hepatocellular carcinoma (TEC) family of kinases. Starting from today, patients with severe alopecia areata can access this treatment at specialist clinics and hospitals islandwide.
“LITFULO represents a significant breakthrough in the treatment of alopecia areata, an autoimmune disease with limited options available for adults and adolescents,” said Deborah Seifert, Cluster Lead, Pfizer Malaysia-Indonesia-Singapore-Philippines (MISP). “The approval of LITFULO marks a significant milestone for the treatment of this condition and its availability in Singapore underscores our commitment to improve patient outcomes.”
Alopecia areata is an autoimmune disease that affects 2% of the general population worldwide.3 In Singapore, the local incidence of alopecia areata is 3.8%.4 Patients with severe alopecia areata are less likely to experience full remission and regrowth, as compared to patients with milder forms of alopecia areata,5 and can be triggered by environmental factors including stress, injury, or illness.6
“Severe alopecia areata is an autoimmune disease that can have significant psychosocial impact beyond just the physical symptoms. It is not just hair loss as this condition can potentially negatively affect a person's self-esteem and resultant quality of life. While the symptoms may start developing at any age, most people start showing signs in their teens, twenties, or thirties,” said Dr. Angeline Yong, Dermatologist, AYD Dermatology. “The availability of LITFULO offers patients, especially the younger ones in their teenage years an efficacious option to tackle hair loss from severe alopecia areata.”
The approval was based on results of the ALLEGRO Phase 2b/3 trial, which enrolled 718 patients with at least 50% scalp hair loss as measured by the Severity of Alopecia Tool (SALT), evaluating the efficacy and safety of LITFULO at 118 sites in 18 countries.7 In this pivotal study, 23% of patients treated with LITFULO 50 mg had 80% or more scalp hair coverage (SALT≤20) after 24 weeks compared to 2% with placebo7. The most common adverse events (AEs) reported in patients with LITFULO 50 mg include headache, nasopharyngitis, upper respiratory tract infection, nausea, and acne. LITFULO was effective and well-tolerated in patients aged 12 years and older with alopecia areata7.
- End -
About LITFULO™ (Ritlecitinib)
LITFULO is an inhibitor of JAK3 and the TEC family kinases. Inhibition of JAK3 and TEC kinase family members by LITFULO may block signaling of cytokines and cytolytic activity of T cells, which is implicated in the pathogenesis of alopecia areata.8,9,10,11
About Alopecia Areata
Alopecia areata is an autoimmune disease characterized by patchy or complete hair loss on the scalp, face, or body.12 ,13 It has an underlying immuno-inflammatory pathogenesis and develops when the immune system attacks the body’s hair follicles, causing hair to fall out14. This hair loss often occurs on the scalp, but it can also affect eyebrows, eyelashes, facial hair, and other areas of the body14. Alopecia totalis (total scalp hair loss) and alopecia universalis (total body hair loss) are types of alopecia areata.14
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 175 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.sg. In addition, to learn more, please visit us on www.Pfizer.com.sg and like us on Facebook at Facebook.com/PfizerSG.
Disclosure Notice: The information contained in this release is as of December 2, 2024. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
PP-LGF-SGP-0007/24OCT2024
References:
1. Olumiant Prescribing Information. Eli Lilly and Company. 24 Aug 2023.
2. Litfulo Prescribing Information. Pfizer Inc. June 2024. Available from: https://labeling.pfizer.com/ShowLabeling.aspx?id=19127
3. Pratt CH, King LE Jr, Messenger AG, Christiano AM, Sundberg JP. Alopecia areata. Nat Rev Dis Primers. 2017 Mar 16;3:17011. doi: 10.1038/nrdp.2017.11. PMID: 28300084; PMCID: PMC5573125.
4. Tan E, Tay YK., Goh CL, Chin Giam Y. The pattern and profile of alopecia areata in Singapore--a study of 219 Asians. Int J Dermatol. 2002 Nov;41(11):748-53. doi: 10.1046/j.1365-4362.2002.01357.x. PMID: 12452996.
5. Fenske DC, Ding Y, Morrow P, Smith SG, Silver MK, Moynihan M, Manjelievskaia J. Comparing the burden of illness in patients with alopecia areata vs atopic dermatitis in the US population from a payer perspective. J Manag Care Spec Pharm. 2023 Apr;29(4):409-419. doi: 10.18553/jmcp.2023.29.4.409. PMID: 36989453; PMCID: PMC10387998.
6. Pfizer. Alopecia Areata. Available at: https://www.pfizer.com/disease-and-conditions/alopecia-areata. Accessed Oct 2024.
7. King B, Zhang X, Harcha WG, et al. Lancet. 2023;401(10387):1518-1529.
8. Xing L, Dai Z, Jabbari A, et al. Nat Med.
9. Howell MD, et al. Front Immunol. 2019;10:2342-2356.
10. Telliez JB, et al. ACS Chem Biol.
11. Xu H, et al. ACS Chem Biol. 2019;14(6):1235-1242.
12. Pratt CH, King LE Jr, Messenger AG, Christiano AM, Sundberg JP. Alopecia areata. Nat Rev Dis Primers. 2017;3:17011
13. Islam N, Leung PSC, Huntley AC, et al. The autoimmune basis of alopecia areata: a comprehensive review. Autoimmun Rev. 2015:14(2):81-89.
14. NIAMS. “Alopecia Areata.” National Institute of Arthritis and Musculoskeletal and Skin Diseases, 2019, www.niams.nih.gov/health-topics/alopecia-areata.