First-Ever Standardized U.S. Treatment Recommendations Issued for Adults with Severe Alopecia Areata; Sun Pharma Welcomes Milestone

First-Ever Standardized U.S. Treatment Recommendations Issued for Adults with Severe Alopecia Areata; Sun Pharma Welcomes Milestone

New treatment recommendations provide clinicians and patients with consensus guidance to effective alopecia areata treatment

Recommendations establish oral JAK inhibitors as primary therapy, closing the gap between medical innovations and access to standardized patient care
 

PRINCETON, N.J., Sept. 22, 2026 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, together with its subsidiaries and/or affiliated companies, "Sun Pharma") today expressed its support for the first standardized United States treatment recommendations for adults with severe alopecia areata (AA). Developed through a rigorous, multi-round survey process, the consensus guidance issued independently by the National Alopecia Areata Foundation (NAAF) and the American Hair Research Society (AHRS) reflect the collective clinical expertise of 30 leading U.S. alopecia areata specialists. The treatment recommendations were published in Journal of the American Medical Association Dermatology (JAMA Dermatology).

AA is an autoimmune disease where the body's immune system mistakenly attacks hair follicles, leading to hair loss not only limited to the scalp, but can also affect other hair bearing body sites. Impacting an estimated 300,000 U.S. adults, severe AA causes more than hair loss; it also carries a significant physical and psychosocial burden for patients. The expert guidance adopts a standardized severity scale that goes beyond scalp hair loss percentage to include psychosocial impact, eyebrow and eyelash involvement, and prior treatment response, more accurately reflecting the challenges of living with severe AA.

"For patients with severe alopecia areata, the absence of standardized treatment recommendations has meant inconsistent and delayed access to effective therapy," said Arash Mostaghimi, MD, MPA, MPH, FAAD, Guidelines Lead and Vice Chair of Clinical Trials and Innovation and Associate Professor of Dermatology at Brigham and Women's Hospital/Harvard Medical School. "The expert panel determined oral JAK inhibitors as an appropriate first-line therapy in combination with supportive resources and adjunctive therapies, bringing consistency to how we treat this disease."

Key outcomes of the consensus process include:

• A standardized definition of severe AA using the Alopecia Areata Scale for Clinical Use, previously published in the Journal of the American Academy of Dermatology
• Oral JAK inhibitors (FDA-approved) established as the primary, long-term treatment of choice
• A framework for adjunctive therapies, like topicals and corticosteroids, tailored by site-specific indication (scalp, facial hair, eyebrows, eyelashes)
• Appropriate alternatives for patients with active atopy (a genetic predisposition to an exaggerated immune response) or history of atopic disease
• A longitudinal management model to guide ongoing patient care and treatment adjustments through trial duration period
• Mental health screening, patient advocacy organization referrals, and cranial prostheses formally integrated as pillars of holistic management

"Many individuals with alopecia areata struggle to find healthcare providers equipped to help them achieve their treatment goals. While the approval of JAK inhibitors was a major milestone in expanding access to effective care, significant gaps remain," said Laura Maciag, Chief Operating Officer and Interim Chief Executive Officer, National Alopecia Areata Foundation (NAAF). "These consensus recommendations aim to further democratize alopecia management by offering actionable guidance that any clinician can readily implement in practice."

Marking a meaningful step forward for patients, clinicians and the broader alopecia areata community, the published consensus recommendations are now available in JAMA Dermatology and can be accessed here. Additional resources are also available from NAAF at www.naaf.org/treatment-recs.  

"These first-ever standardized U.S. treatment recommendations mark a defining moment for the alopecia areata community," said Ahmad Naim, MD, Senior Vice President, North America Chief Medical Officer, Sun Pharma. "As the maker of LEQSELVI^® (deuruxolitinib), an FDA-approved oral JAK inhibitor for adults with severe alopecia areata, we see these consensus-based recommendations as an impactful advancement for healthcare providers toward further improving clinical decision making and care. We remain committed to providing access to effective and safe long-term treatment for every patient and clinician we serve."

About LEQSELVI^®
LEQSELVI (deuruxolitinib) 8 mg tablets is an oral selective inhibitor of Janus kinases JAK1 and JAK2 FDA-approved for the treatment of adults with severe alopecia areata. Alopecia areata is an autoimmune disease in which the immune system attacks hair follicles, resulting in partial or complete loss of hair on the scalp and body. Alopecia areata may affect up to 2.5% of the United States and global population during their lifetime. The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or together with the scalp. Onset of the disease can occur throughout life and affects both women and men. Alopecia areata can be associated with serious psychological consequences, including anxiety and depression. There are currently limited approved treatment options available for alopecia areata.

Please click here for full Prescribing Information Including BOXED WARNING and Medication Guide.

LEQSELVI Important Safety Information & Use

What is LEQSELVI (deuruxolitinib)?
LEQSELVI is used to treat adults with severe hair loss (alopecia areata).
It is not known if LEQSELVI is safe and effective in children.

Who should not take LEQSELVI?
Do not take LEQSELVI if you are a poor metabolizer of CYP2C9 medicines or are taking moderate or strong CYP2C9 inhibitors. Before starting treatment, your healthcare provider should test you for CYP2C9 variants.  Tell your healthcare provider if you take moderate or strong CYP2C9 inhibitor medicines. Ask your healthcare provider or pharmacist if you are not sure.

What is the most important safety information I should know about LEQSELVI?
LEQSELVI is a medicine that affects your immune system and can lower the ability of your immune system to fight infections. Some people have had serious infections during treatment with LEQSELVI. Some people may die from these infections... Your healthcare provider should test you for TB before starting treatment with LEQSELVI and should watch you closely for signs and symptoms of TB during treatment. You should not start taking LEQSELVI if you have any kind of infection unless your healthcare provider tells you it is okay

There may be an increased risk of major cardiovascular events in people 50 years of age and older who have at least one heart disease risk factor and are taking a medicine in the class of medicines called JAK inhibitors, especially if they are a current or past smoker.
LEQSELVI may increase your risk of certain cancers by changing the way your immune system works.

Blood clots in the veins of your legs, lungs or brain (cerebral venous sinus thrombosis, CVT) can happen in some people during treatment with LEQSELVI. These may be life-threatening.

Some people taking LEQSELVI can get tears in their stomach or intestines.

If you have diabetes, your healthcare provider may instruct you to check your blook sugar levels more often during treatment with LEQSELVI. Call your healthcare provider if you have any problems with low blood sugar (hypoglycemia).  

Before you start and taking LEQSELVI and during treatment, your healthcare provider should do blood tests to check for increased fat levels in your blood, Low white and/or red blood cell counts. You should not take LEQSELVI if your white blood cell or red blood cell counts are too low.

What should I tell my healthcare provider before starting LEQSELVI?
Tell your healthcare provider if you have an infection; are a current or past smoker; have had a heart attack, or other heart problems or stroke; have had blood clots in your legs, lungs or brain; have kidney problems; have liver problems; have any stomach area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestine; have low red or white blood cell counts; or have recently received or are scheduled to receive a vaccine.

Females who are able to become pregnant should use effective birth control (contraception) during treatment with LEQSELVI. Talk to your healthcare provider if you are planning to become pregnant. You should not breastfeed during treatment with LEQSELVI and for one day after the last dose.

What else should I be aware of when taking LEQSELVI?
Your healthcare provider should do blood tests before you start taking LEQSELVI and during treatment to check for increased fat (lipid) levels in your blood (triglycerides and cholesterol), low red blood cell counts, or low white blood cells.

How should I take LEQSELVI?
Take LEQSELVI 2 times a day with or without food.

What are the possible side effects of LEQSELVI?
The most common side effects of LEQSELVI include:

These are not all of the possible side effects of LEQSELVI. Call your healthcare provider for medical advice about side effects.

To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

About the NAAF/AHRS DELPHI Consensus Treatment Recommendations
The treatment recommendations were developed using a validated Delphi consensus methodology, achieving ≥70% expert agreement across all core recommendations. A steering group of 30 AA specialists reviewed published data on 29 treatments, reaching consensus on a standardized definition of disease severity, treatment pathways for primary and adjunctive therapies, and a longitudinal management model. The treatment recommendations are designed as a living resource, with plans for ongoing updates as new clinical evidence emerges.

About Sun Pharmaceutical Industries Limited (CIN - L24230GJ1993PLC019050)
Sun Pharma is a leading global pharmaceutical company with a presence in Innovative Medicines, Generics and Consumer Healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the US as well as Global Emerging Markets. Sun's high growth Global Innovative Medicines portfolio spans innovative products in dermatology, ophthalmology, and oncodermatology and accounts for about 22% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across five continents. Sun Pharma is proud of its multi-cultural workforce drawn from over 50 nations.

For further information, please visit www.sunpharma.com and follow us on LinkedIn & X.

Disclaimer
Statements in this "Document" describing the Company's objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be "forward looking  statements" within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied. The Company undertakes no obligation to update or revise forward looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. 

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