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Fda approves second yale-researched treatment for alopecia areata.

A side by side comparison of the same patient before and after treatment.

Just a year after the U.S. Food and Drug Administration (FDA) approved the first treatment for severe alopecia areata, the federal agency has approved a second treatment for the disfiguring skin disease — both the result of pioneering research by the same Yale dermatologist.

On June 23, the FDA announced its approval for the use of ritlecitinib — a Janus kinase (JAK) inhibitor — to treat alopecia areata in both adolescents and adults. The medicine, taken orally, goes by the product name Litfulo.

Alopecia areata is an autoimmune disease characterized by sudden, often disfiguring, loss of hair. It is the second most common cause of hair loss, affecting up to 7 million people in the United States.

Dr. Brett King , an associate professor of dermatology at Yale School of Medicine, worked with pharmaceutical company Pfizer to conduct a series of clinical trials with ritlecitinib. He worked with Eli Lilly and Company on clinical trials for the earlier medicine — baricitinib (which goes by the product name Olumiant), approved as a treatment for patients with severe alopecia areata in June 2022 .

King’s groundbreaking work with JAK inhibitors, which were originally designed to treat rheumatoid arthritis and myelofibrosis (a rare blood cancer), has shown significant potential to treat an array of intractable skin diseases, including eczema, erosive lichen planus, vitiligo, granuloma annulare, and sarcoidosis.

King spoke with Yale News about this latest FDA approval.

How does FDA approval for ritlecitinib change the treatment landscape for people with alopecia areata?

Brett King: Ritlecitinib [Litfulo] changes the treatment landscape for people with alopecia areata enormously. Last year, history was made when baricitinib [Olumiant] was FDA approved for the treatment of adults with severe alopecia areata. But alopecia areata affects people of all ages and, indeed, it commonly affects children of all ages. Ritlecitinib is approved in patients ages 12 years and older.

Childhood and adolescence are such vulnerable times, and children and adolescents have so much to do and learn and become during these years. It is challenging enough to be a kid, but when alopecia areata happens and suddenly one has big bald spots or is completely bald and missing eyebrows, the normal trajectory of that kid’s life, and the family’s life, too, can be derailed. Kids withdraw from sports and other social activities, and even from school. Extreme sadness and anxiety are common. It is awful. There is a way out of the darkness, however, and that is to regrow the hair that was lost, to restore the person as they had been prior to alopecia areata.

Normalcy is so important for everybody, but especially when we are developing. So it is easy to understand what a monumental breakthrough it is to have a medicine, ritlecitinib, approved for adolescents. Ritlecitinib restores normalcy and will make life better — literally will change life — for so many people.

When can patients in the U.S. expect ritlecitinib to be available for use?

King: Hopefully in the days or weeks ahead.

You have been at the center of two FDA approvals for major treatments of alopecia areata in two years. Has that sunk in yet — and how does that make you feel?

King: These new medicines for alopecia areata are historic, and I feel super fortunate to be a part of their development. Being a doctor is amazing because I get to share in the lives of others, hopefully making those lives better. It happens one person at a time, though. To have played a central role in the development of treatments for alopecia areata and other diseases — treatments that doctors around the world will give to thousands and thousands (or even millions) of people to make their lives better — is really incredible. We are all a part of something bigger than ourselves, and for me this experience highlights that as well as the possibility that we can change the world.

What are you working on next?

King: The next horizon is approval of these and other treatments for younger patients. Remember, alopecia areata is not uncommon in pre-adolescents. Also, JAK inhibitors do not work for everybody with alopecia areata, and so work needs to be done both to understand why that is and to develop treatments other than JAK inhibitors. The goal is for everybody to be able to have effective treatment. We have come so, so far but we still have a ways to go. It’s exciting.

• New Alopecia Areata treatment aims to help adults and adolescents
• FDA approves alopecia areata treatment with roots at Yale
• New trials for alopecia areata treatment are a success

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Can we finally reverse balding with these new experimental treatments?

Male pattern baldness could soon be a thing of the past, with new hair loss treatments beginning to show tantalising results

By Joshua Howgego

26 September 2023

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I’LL level with you: a part of me didn’t want to write this story. When I first realised that I was losing my hair, I found it important to mention it often in conversation. I was so embarrassed about it that I was trying some sort of reverse psychology. But I soon realised that if there was one thing less attractive than my balding head, it was how much I was talking about it. I am joking, of course: there is nothing wrong with being bald. Still, for me, the prospect is terrifying. My hair is a big part of my identity, so to lose it is crushing.

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In a field…

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Studies Uncover New Approaches to Combat Hair Loss in Men and Women

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Two recent studies highlight novel ways to combat pattern hair loss in men and women using small molecules such as JAK inhibitors that reawaken dormant hair follicles, as well as stem cell therapies aimed at growing new follicles. 

In the first study, researchers led by Angela Christiano, PhD , the Richard & Mildred Rhodebeck Professor of Dermatology at Columbia University Vagelos College of Physicians and Surgeons, discovered previously unknown cells that keep mouse hair follicles in a resting state and show that inhibiting the activity of these cells can reawaken dormant follicles.

In a second study, Christiano’s team created a way to grow human hair in a dish , which could open up hair restoration surgery to more people, including women, and improve the way pharmaceutical companies search for new hair-growth drugs.

Study Discovers Cells That Put Hair Follicles to Sleep

Cross section of a hair follicle. Image: Angela Christiano / Columbia University Irving Medical Center.

In male and female pattern baldness, many hair follicles still exist but are dormant. The search for new drugs that reawaken follicles and induce hair growth has been limited by the field’s focus on finding drugs that work along the same pathways as finasteride and minoxidil, the only two drugs currently available for men with male pattern baldness. 

Christiano and her colleagues previously discovered a new pathway, called JAK-STAT, that is active inside the stem cells of resting hair follicles and keeps them in a dormant state. They previously demonstrated that JAK inhibitors applied to mouse skin are a potent way to reawaken resting hair follicles in mice. 

In their latest study, the researchers wanted to get a detailed picture of the natural processes that keep follicles dormant, so they looked for factors that controlled the JAK pathway activity in the hair follicle. 

New Cells Called Trichophages

The search revealed a previously unknown immune-related cell type that produces a substance known as Oncostatin M that keeps the follicles in a state of dormancy. “Rare subsets of immune cells were previously difficult to identify in whole skin, but this work was facilitated by our ability to sequence individual cells and pinpoint the ones making Oncostatin M,” says Etienne Wang, PhD, first author of the study. These cells are most similar to macrophages, which are scavenger cells of the immune system, and the team found them in close association with resting hair follicles.

The researchers named these cells trichophages, after the Greek word tricho for hair.

Targeting the trichophages can also turn on the hair cycle. By using small molecule inhibitors and antibodies to block Csf1R, a receptor on the trichophages, the researchers could block the flow of Oncostatin M and restart the hair cycle. 

Reawakening Dormant Hair Follicles with New Drugs

“Our previous studies implicated JAK-STAT signaling as one potential new therapeutic pathway for hair loss disorders by targeting hair follicle stem cells with JAK inhibitors,” Christiano says. (A biotech company recently reported results of a small phase 2 trial of a topical JAK-STAT inhibitor based on these studies.) “Here, we show that blocking the source of the JAK activating signal outside the hair follicle is another way to target this mechanism.”

Most drug development has focused on treatments for male pattern hair loss, and the majority of clinical trials are conducted exclusively in men.  

“These new pathways may lead to new treatments for both men and women suffering from hair loss, since they appear to be acting independently of male hormone pathways,” Christiano says. “Especially if treatments are used topically, that could avoid the related side effects seen with finasteride and minoxidil.”

Growing New Hair Follicles in a Dish

In a second study, aimed at using stem cells for hair growth, the Columbia researchers have created a way to grow human hair in a dish, which could open up hair restoration surgery to more people, including women, and improve the way pharmaceutical companies search for new hair growth drugs.

It is the first time that human hair follicles have been entirely generated in a dish, without the need for implantation into skin.

Using 3D-Printing to Stop Hair Loss

For years it’s been possible to grow mouse or rat hairs in the lab by culturing cells taken from the base of existing follicles. 

“Cells from rats and mice grow beautiful hairs,” Christiano says. “But for reasons we don’t totally understand, human cells are resistant.”

To break the resistance of human hair cells, Christiano has been trying to create conditions that mimic the 3D environment human hair cells normally inhabit. The lab first tried creating little spheres of cells inside hanging drops of liquid. But when the spheres were implanted in mice, the results were unpredictable: The cells from some people created new hair while others didn’t.

3D Printing Creates Patterned Hair Follicles

In the new study, Christiano’s team exploited the unique capability of 3D printers to create a more natural microenvironment for hair follicle growth. 

The researchers used 3D printing to create plastic molds with long, thin extensions only half a millimeter wide. “Previous fabrication techniques have been unable to create such thin projections, so this work was greatly facilitated by innovations in 3D printing technology,” says Erbil Abaci, PhD, first author of this study. 

After human skin was engineered to grow around the mold, hair follicle cells from human volunteers were placed into the deep wells and topped by cells that produce keratin. The cells were fed a cocktail of growth factors spiked with ingredients, including JAK inhibitors, that the lab has found stimulates hair growth. 

After three weeks, human hair follicles appeared and started creating hair.

Hair Farms Could Expand Availability of Hair Restoration

Though the method needs to be optimized, engineered human hair follicles created in this way could generate an unlimited source of new hair follicles for patients undergoing robotic hair restoration surgery.

Hair restoration surgery requires the transfer of approximately 2,000 hair follicles from the back of the head to the front and top. It is usually reserved for male patients whose hair loss has stabilized and who have enough hair to donate.

“What we've shown is that we can basically create a hair farm: a grid of hairs that are patterned correctly and engineered so they can be transplanted back into that same patient's scalp,” Christiano says. 

“That expands the availability of hair restoration to all patients—including the 30 million women in the United States who experience hair thinning and young men whose hairlines are still receding. Hair restoration surgery would no longer be limited by the number of donor hairs.”

The engineered follicles also could be used by the pharmaceutical industry to screen for new hair growth drugs. Currently, high throughput screening for new hair drugs has been hampered by the inability to grow human hair follicles in a lab dish. No drugs have been found by screening; the only two approved for the treatment of pattern hair loss—finasteride and minoxidil—were initially investigated as treatments for other conditions.  

The team hopes that cultured hair farms will open up the ability to perform high throughput drug screens to identify new pathways that influence hair growth.

The first study, titled “ A Subset of TREM2+ Dermal Macrophages Secretes Oncostatin M to Maintain Hair Follicle Stem Cell Quiescence and Inhibit Hair Growth ,” was published in Cell Stem Cell.

Other authors: Etienne C.E. Wang (Columbia University Irving Medical Center and National Skin Center, Singapore), Zhenpeng Dai (CUIMC), Anthony W. Ferrante (CUIMC), and Charles G. Drake (CUIMC).

The research was supported by the National Skin Center of Singapore, the National Medical Research Council of Singapore, the Locks of Love Foundation, and the National Institutes of Health (S10OD020056, P30AR069632, and P50AR070588).

Dr. Christiano is a consultant and shareholder for Aclaris Therapeutics Inc., a consultant for Dermira Inc., and recipient of grant funding from Pfizer Inc. Dr. Drake has served as a paid consultant for Agenus, Bayer, BMS, F-Star, Janssen, Merck, Pfizer, Pierre Fabre, Roche/Genentech, and Shattuck Labs. He has ownership interest in Compugen, Harpoon, Kleo, Potenza, Tizona, and Werewolf.

Columbia University has licensed intellectual property related to these studies to Aclaris Therapeutics Inc. 

The second study, titled “ Tissue engineering of human hair follicles using a biomimetic developmental approach ,” was published in Nature Communications. 

Other authors: Hasan Erbil Abaci, Abigail Coffman, Yanne Doucet, James Chen, Joanna Jacków, Etienne Wang, Zongyou Guo, Jung U. Shin (all from Columbia University Vagelos College of Physicians and Surgeons) and Colin A. Jahoda (Durham University, Durham, U.K.).

The research was supported by the NIH (National Center for Advancing Translational Sciences grant UH2EB017103; National Institute of Arthritis and Musculoskeletal and Skin Diseases grants K01AR072131 and P30AR069632); New York State Stem Cell Science (SDH C029550); an Ines Mandl Research Foundation Fellowship; and a CUIMC Precision Medicine Research Fellowship (with funds from NIH grant  UL1TR001873 ).

Dr. Christiano and Dr. Jahoda are founders of Rapunzel Bioscience Inc., which focuses on developing regenerative therapies for skin and hair disorders. The remaining authors declare no competing interests.

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FDA Approves First Drug to Treat Hair Loss Caused By Alopecia

In a clinical trial with 1200 patients, more than half grew their hair back after a year

Elizabeth Gamillo

Daily Correspondent

The U.S. Food and Drug Administration (FDA) has approved the drug  Olumiant  (baricitinib) for adult patients with severe alopecia areata, an immune disorder that often results in hair loss. The medicine is the first FDA approval of a systemic or full-body drug for the condition, per a  statement .

The drug was originally developed by the pharmaceutical company  Eli Lilly  and has already been on the market for about four years for treating rheumatoid arthritis and other autoimmune diseases. Oluminant was studied in two trials for the treatment of alopecia areata, and the results were published last month in the  New England Journal of Medicine .  

Alopecia areata  is a disease that occurs when the immune system attacks hair follicles, causing hair loss. Hair loss is usually found on the head and face but can occur in small, round, coin-shaped patches anywhere on the body, according to the National Institutes of Health. About 700,000 individuals in the United States are living with alopecia areata. Roughly 40 percent of those individuals have a severe form of the autoimmune disorder, meaning that they are missing at least half of the hair on their scalp,  STAT  reports.

Until now, no approved treatment existed to make hair grow back in patients with alopecia areata. Those with the disorder had to rely on unapproved creams, cosmetic solutions and injections to manage their condition, Jonathan Wosen and Akila Muthukumar report for  STAT . "Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia," Kendall Marcus, director of the Division of Dermatology and Dentistry in the FDA's Center for Drug Evaluation and Research, says in a statement. "Today's approval will help fulfill a significant unmet need for patients with severe alopecia areata."

Eli Lilly's drug prevents the immune system from attacking hair follicles. Pharmaceutical companies like Pfizer and Concert Pharmaceuticals are working on similar drugs to Oluminant.

The phase III trials for Eli Lilly's drug involved 1,200 patients with severe alopecia areata. Study participants either took a daily pill containing two milligrams or four-milligrams of the drug, or a placebo containing no medication. Almost 40 percent of individuals who took the higher drug dose had complete or near-complete hair regrowth after 36 weeks, and after a year, nearly half of patients had their hair back, reports the  New York Times . Patients who received the drug also reported regrowth of hair along their eyelashes and eyebrows.

Mild side effects were reported and included an increased risk for acne, urinary tract infections, headaches, high cholesterol and other infections. The drug’s list price is $2,500 for a one-month supply of the two milligram dose. But, Patrik Jonsson, Eli Lilly's president of immunology, told  STAT that the company is dedicated to making sure out-of-pocket costs for the drug are as little as $5 a month for insured individuals and $25 for those who are uninsured.

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Elizabeth Gamillo is a daily correspondent for  Smithsonian and a science journalist based in Milwaukee, Wisconsin. She has written for Science magazine as their 2018 AAAS Diverse Voices in Science Journalism Intern.