The FDA Approves Deuruxolitinib for Severe Alopecia in Adults

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The US Food and Drug Administration (FDA) has approved deuruxolitinib (Leqselvi; Sun Pharma), an oral Janus Kinase (JAK) inhibitor, for the treatment of severe alopecia areata in adults. Deuruxolitinib operates by selectively inhibiting JAK1 and JAK2, proteins involved in the immune signaling pathways believed to contribute to hair loss in alopecia areata.1 The drug's approval is based on the results of 2 phase 3 clinical trials, THRIVE-AA1 (NCT04518995) and THRIVE-AA2 (NCT04797650), which together included 1220 patients with at least 50% scalp hair loss as measured by the Severity of Alopecia Tool (SALT).²

In these trials, patients started with an average of only 13% scalp hair coverage. By week 24, one-third of the patients treated with deuruxolitinib achieved at least 80% scalp hair coverage, with some achieving up to 90% coverage. The studies demonstrated a consistent upward trend in hair regrowth among patients, with no observed plateau in efficacy at the 24-week mark. The most common adverse events reported in clinical trials included headache, acne, and nasopharyngitis. More serious side effects, though rare, may include serious infections, malignancies, thrombosis, gastrointestinal perforations, and certain laboratory abnormalities. Due to these risks, deuruxolitinib is contraindicated in patients who are CYP2C9 poor metabolizers or those taking moderate or strong CYP2C9 inhibitors.

James Song, MD, director of clinical research at Frontier Dermatology Partners in Seattle, Washington recently shared with Dermatology Times that he looks forward to seeing results of long-term data. He said after his session at the 2024 Fall Clinical Dermatology Conference for PAs and NPs, “Two different doses that were studied, showed some of the most robust efficacy we've seen and some of the fastest responses that we've seen out of any JAK inhibitor. Now there are some safety things that came up with a higher dose of deuruxolitinib. We did see there was a higher rates of blood clots, and so the FDA actually didn't make the patients drop down to the lower dose and so we will need more long-term data really to understand the safety profile of this newer JAK inhibitor.”³

In a review published earlier this year on investigational treatments for alopecia areata, investigators shared confidence in JAK inhibitors and wrote, “JAK inhibitors are a safe and efficacious treatment of moderatetosevere alopecia areata. Early intervention, regardless of severity, allows for improved treatment efficacy. It is uncertain how long patients should remain on JAK inhibitors; discontinuation often leads to relapse. A blackbox warning for JAK inhibitors was extrapolated from safety data in a rheumatoid arthritis cohort; recent meta-analyses of JAK inhibitors used in dermatology cohorts do not demonstrate the same risk profile.”²

The approval of deuruxolitinib has been met with optimism from both the medical community and patient advocacy groups. Nicole Friedland, president and CEO of the National Alopecia Areata Foundation (NAAF), welcomed the new treatment as a significant advancement for individuals affected by the condition. She said in a press release, “Alopecia areata is an autoimmune disease, with significant physical, emotional and financial impacts that go beyond hair loss. Today's announcement empowers the alopecia community with even more choices, to which NAAF is committed, and provides another important option for those living with severe alopecia areata."¹

Sun Pharma, the developer of deuruxolitinib, is introducing an access program to assist eligible patients in starting and adhering to the treatmentin an effort to remain committed to supporting the alopecia areata community and enhancing patient care.

References

1. U.S. FDA approves LEQSELVI™ (deuruxolitinib), an oral jak inhibitor for the treatment of severe alopecia areata. News release. Sun Pharmaceutical Industries Limited. July 26, 2024. Accessed July 26, 2024. https://www.prnewswire.com/news-releases/us-fda--approves-leqselvi-deuruxolitinib-an-oral-jak-inhibitor-for-the-treatment-of-severe-alopecia-areata-302207222.html?tc=eml_cleartime
2. Chim I, Ghiya R, Sinclair RD, Eisman S. Novel investigational drugs for alopecia areata and future perspectives. Expert OpinInvestig Drugs. 2024;33(5):441-449. doi:10.1080/13543784.2024.2348062
3. Buchanan L, Song J. Navigating the Alopecia Areata Treatment Landscape. Dermatology Times. June 1, 2024. Accessed July 26, 2024. https://www.dermatologytimes.com/view/navigating-the-alopecia-areata-treatment-landscape