What You Need to Know about the FDA Approval of Ritlecitinib (LITFULO) for Alopecia Areata
Donovan Medical Donovan Medical
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 Published On Jun 29, 2023

***RECORDING FROM LIVE PUBLIC WEBINAR HELD BY DR DONOVAN ON WED JUN 28 2023******

On Jun 23, 2023 the US Food and Drug Administration approved Ritlecitinib (Litfulo) for the treatment of severe alopecia areata. This marks the second drug approved for severe forms of alopecia areata and comes just 12 months after the first drug (baricitinib) was FDA approved.

Ritlecitinib (now to be marketed as Litfulo) is approved for individuals 12 and over with severe alopecia. Similar to baricitinib, the drug does not help everyone but does help about 25 %-30% of patients achieve really good regrowth after six months of using the drug. Similar to baricitinib, many patients do not respond completely to the medication - for reasons that are not entirely clear. The drug will be needed lifelong for most patients.

On Wednesday June 28, 2023, Dr. Donovan hosted a public webinar discussing ritlecitinib in more depth. He reviewed how well the drug works, the potential side effects, the unknown issues that still exist with the drug and review how Ritlecitinib compares to baricitinib. This is a recording of the complete webinar.

TIMESTAMPS for RECORDING:

Introduction to the Baricitinib (Olumiant) "BRAVE-AA" Clinical Trials (starts at 6:48)
The Baricitinib (Olumiant) - 104 week data (starts at 15:11)
Introduction to the Ritlecitinib (Litfulo) "Allegro" Trials (starts at 19:01)
Comparing Baricitinib (Olumiant) and Ritlecitinib (Litfulo) Data (starts at 28:03)
Prescribing JAK Inhibitors in Real Practice (starts at 45:16)
Contraindications to using a JAK Inhibitor (starts at 48:02)
Do Patients on JAK Inhibitors maintain their nice results? (starts at 57:22)
Question and Answer Period (starts at 1:05:06)

REFERENCES

King B et al. Two Phase 3 Trials of Baricitinib for Alopecia Areata. N Engl J Med. 2022 Mar 26.

King B et al. Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b-3 trial. Lancet. 2023 May 6;401(10387):1518-1529.

Kwon  O et al. Efficacy and Safety of Baricitinib in Patients with Severe Alopecia Areata over 52 Weeks of Continuous Therapy in Two Phase III Trials (BRAVE-AA1 and BRAVE-AA2). Am J Clin Dermatol. 2023 Mar 1;1-9.

King B, Ohyama M, Senna M, et al. Outcomes of Down Titration in Patients with Severe Scalp Alopecia Areata Treated with Baricitinib 4 mg: Week 104 Data from BRAVE AA-2. Paper presented at the American Academy of Dermatology 2023 Annual Meeting, March 17-21, New Orleans, LA. Accessed May 1 2023.

Senna M et al. Long-Term Efficacy of Baricitinib in Alopecia Areata: 104-Week Results from BRAVE AA-1 and BRAVE AA-2. Paper presented at the AAD 2023 Annual Meeting, March 17-21, New Orleans, LA. Accessed May 1 2023.

Donovan J. The Evolving Story of JAK Inhibitors for Treating Alopecia Areata: A Review of Current Progress and Future Directions. Skin Therapy Lett. 2023 May;28(3):1-7.

Donovan J. Pulmonary Embolism in Open Label Extension Trial of Deuruxolitinib Stops 12 mg BID Arm. https://donovanmedical.com/hair-blog/...

#alopeciaareata #jakinhibitors #ritlecitinib #alopecia #alopeciatreatment

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