FDA Approves Deuruxolitinib for Alopecia Areata

The FDA approved deuruxolitinib as a first-line treatment method for adults with moderate to severe alopecia areata. | Image Credit: Surendra - stock.adobe.com

The FDA has approved deuruxolitinib as a first-line treatment for adults with moderate to severe alopecia areata (AA).¹

Deuruxolitinib, developed by Sun Pharma, is an oral selective inhibitor of Janus kinases JAK1 and JAK2, typically dosed at 8 mg twice daily. Currently, AA does not have a cure and relies heavily on the limited treatment options available to reduce symptoms and stimulate hair regrowth.

"Deuruxolitinib is an important addition to the AA treatment toolbox. With each new medicine approved for AA, more patients will be successfully treated. It’s amazing how far we have come in so short a time," commented Brett King, MD, PhD, associate professor of dermatology at Yale Medicine.

The standard of care for adult patients with AA is the oral selective JAK inhibitor, baricitinib.² Other forms of treatment include corticosteroids, topical immunotherapy, cyclosporine A, methotrexate, and azathioprine.

Abhay Gandhi, CEO-North America, Sun Pharma, stated, “We believe that deuruxolitinib has the potential to be an important new treatment option for people who continue to struggle every day with the chronic nature of alopecia areata.”¹

The approval is supported by the THRIVE-AA1 (NCT04518995) and THRIVE-AA2 trials (NCT04797650), randomized, double-blind, placebo-controlled clinical trials presented at the 2024 American Academy of Dermatology Annual Meeting.³ These analyses included adults aged 18 to 65 years with moderate to severe AA located in the US, Canada, and Europe.¹

Patients were randomized to receive either 8 mg twice daily, 12 mg twice daily, or a placebo over the course of 24 weeks. At baseline, patients had average Severity of Alopecia Tool (SALT) scores of 85.9 and 87.9 of 100 for THRIVE-AA1 and THRIVE-AA2, respectively.

The THRIVE-AA1 trial looked for key efficacy outcomes among patients with AA.⁴ Results from this trial declared the twice-dailky 8-mg and 12-mg doses of deuruxolitinib met the primary efficacy end point, a SALT score of 20 or less by week 24. As early as 8 weeks, significant hair regrowth of scalp hair began, and this continued throughout the study. The deuruxolitinib 12-mg twice0-a-day dose was found to be superior to the 8 mg dose.

In THRIVE-AA2, the primary outcome was the safety of deuruxolitinib in patients with AA.⁵ Both the 8-mg and 12-mg twice-daily doses were well tolerated. More than 95% of treatment emergent adverse events (TEAEs) were mild to moderate in severity; there were no serious TEAEs in the study. Minimal cases of AEs consisted of serious infections, appendicitis, COVID-19, and meningitis; discontinuation due to TEAEs was not common; and herpes zoster was considered rare. There were no thromboembolic events (deep vein thrombosis/pulmonary embolism/) or patient deaths.

Arash Mostaghimi, MD, MPA, MPH, assistant professor of dermatology, director of the inpatient dermatology consult service, and co-director of the Complex Medical Dermatology Fellowship at Brigham & Women’s Hospital spoke with The American Journal of Managed Care^® regarding his involvement in the THRIVE trials.

He noted, “I enrolled patients in both of these studies, and the takeaway from the overall studies is that we have another efficacious treatment for people with moderate to severe alopecia areata. Patients demonstrated scalp hair regrowth and eyebrow and eyelash regrowth, and concurrent improvement in psychosocial outcomes.”

When Mostaghimi was asked how the THRIVE trials might inform future research directions for AA treatment, he stated, “The focus of the THRIVE trials on quantitative eyebrow and eyelash growth add another dimension that in correlation with patient-reported and other clinical reported outcomes gives us another perspective on a critical area of interest for patients who have severe hair loss. But the best news is to have an additional choice, because having only 2 options is limiting and the more options we have, I think the better patients will do.”

The newly approved deuruxolitinib is significant for adult patients with moderate to severe AA because this inflammatory disorder does not have a cure and relies heavily on various treatments to reduce symptoms.

Nicole Friedland, president and CEO of the National Alopecia Areata Foundation (NAAF) commented, “Alopecia areata is a chronic autoimmune disease with psychological and emotional effects, and there is still significant unmet medical need in the community. We are excited that the FDA is elevating another potential treatment option for this serious medical condition.”¹

References

1. Sun Pharma announces US FDA filing acceptance of new drug application (NDA) for deuruxolitinib. News release. Sun Pharma. October 6, 2023. Accessed July 16, 2024. https://sunpharma.com/wp-content/uploads/2023/10/Sun-Pharma-Announces-US-FDA-Filing-Acceptance-for-Deuruxolitnib.pdf

2. Santoro C. Review finds JAK inhibitors more effective for moderate to severe AA compared with established therapies. AJMC^®. March 13, 2024. Accessed July 16, 2024. https://www.ajmc.com/view/review-finds-jak-inhibitors-more-effective-for-moderate-to-severe-aa-compared-with-established-therapies

3. Santoro C. Deuruxolitinib demonstrates efficacy, tolerability in patients with moderate to severe AA. AJMC^®. March 14, 2024. Accessed July 16, 2024. https://www.ajmc.com/view/deuruxolitinib-demonstrates-efficacy-tolerability-in-patients-with-moderate-to-severe-aa

4. Senna MM, King B, Mesinkovska AN, Mostaghimi A, Hamilton C, Cassella J. Efficacy of the oral JAK1/JAK2 inhibitor deuruxolitinib in adult patients with moderate to severe alopecia areata: pooled results from the multinational double-blind, placebo-controlled THRIVE-AA1 and THIVE-AA2 phase 3 trials. Presented at: AAD Annual Meeting; March 8-12, 2024; San Diego, CA. Abstract 51840.

5. King B, Senna MM, Mesinkovska AN, Mostaghimi A, Hamilton C, Cassella J. Pooled safety assessments from the multinational phase 3 THRIVE-AA1 and THRIVE-AA2 trials of deuruxolitinib in adult patients with moderate to severe alopecia areata. Presented at: AAD Annual Meeting; March 8-12, 2024; San Diego, CA. Abstract 54022.