FDA Approves First Drug of Its Kind for Severe Alopecia

If you have alopecia areata, you’re probably curious about whether hair loss products can improve the condition. U.S. FDA has approved Eli Lilly’s drug, Olumiant, which is considered the first to treat severe hair loss. No, not all products marketed for treating or replacing lost hair are FDA-approved; it’s essential to verify their safety and efficacy before use. The higher dose provided even better outcomes for people with extensive hair loss caused by alopecia areata. King, the principal investigator for the trials, noted that two other similar drugs, from Pfizer and Concert Pharmaceuticals, are also in development to treat the condition and could be approved by the FDA within the next few years. Dr. Luis Garza, a dermatologist at the Johns Hopkins University School of Medicine who treats people with alopecia, said he’s had patients quit their jobs or avoid going out in public altogether over the stress of losing their hair.

  • He said that it is expected that patients will need to continue on the medication on a long-term basis in order to maintain hair growth.
  • That stress disrupts the hair growth cycle, pushing more hairs into the shedding (telogen) phase while fewer new ones grow in.
  • The higher dose provided even better outcomes for people with extensive hair loss caused by alopecia areata.
  • Analysis of the efficacy of ADSCs and their derivatives in both preclinical and clinical settings highlight their potential to stimulate hair regeneration.

Mushroom-derived growth factors

As a DHT blocker, finasteride slows down testosterone’s conversion to dihydrotestosterone to stop this hormone from affecting hair follicles. Hair loss is a common condition caused by a variety of factors, including endocrine disorders, stress, nutritional and metabolic imbalances, diseases and infections, genetic predispositions, and aging 1. Studies suggest that over 50% of the global population will experience some degree of hair loss in their lifetime, with androgenetic alopecia (AGA) and alopecia areata (AA) being the most prevalent types. The underlying mechanism of AGA involves hair follicles being highly sensitive to dihydrotestosterone (DHT), an androgen metabolite, which leads to the gradual shrinkage of hair follicles, shortening of the anagen phase, and eventually, hair loss 2. This condition not only affects physical appearance but also significantly impacts the mental health of affected individuals, often leading to social isolation, depression, and anxiety 3,4,5. Despite these promising developments, several challenges remain, including variability in patient response, delayed or non-response, relapse after discontinuation, and open questions regarding long-term safety.

Current Use of JAK Inhibition in AA

fda approves first drug to treat hair loss caused by alopecia

Williams does not recommend transplants, because alopecia areata is an autoimmune disorder. Even if a transplant is done after the disease has been treated, there is a risk that the transplants will not hold or that the process will reactivate the alopecia, causing more hair loss, he says. Plus, if the product isn’t effective, you could be delaying proper treatment, which may only worsen hair loss later on.

ADSCs exhibit significant antioxidant properties, which further contribute to their effectiveness in promoting hair growth. These proteins provide antioxidant and anti-apoptotic protection to dermal fibroblasts and epidermal keratinocytes, shielding them from free radical damage. Moreover, ADSCs help eliminate intracellular reactive oxygen species (ROS) by accelerating mitochondrial autophagy and enhancing the expression of antioxidant enzymes like catalase and superoxide dismutase (SOD).

FDA approves first-of-a-kind hair loss drug for severe alopecia

Telogen effluvium happens when major life events knock hair’s natural cycles out of whack and can be triggered by illness, surgery, hormonal shifts, stress, nutritional deficiency — or rapid weight loss. “Normally, only about 10 percent of hair follicles are in the telogen phase, but during TE, that can jump to 40 percent,” says Jodi LoGerfo, DNP, a hair-loss specialist. We typically shed 50 to 100 hairs a day, but in telogen effluvium, it can be 300 to 500. Most hair loss is rooted in genetics or driven by chemical processes within the body. Hair growth products aim to counteract or neutralize those processes—but as with any long-term treatment, consistency is key to seeing results. “If you stop your regimen, you can lose the progress you’ve made, and your body’s natural chemistry will revert,” Buechner explains.

Evaluating Current and Emergent JAK Inhibitors for Alopecia Areata: A Narrative Review

Ritlecitinib is a type of medication known as a JAK inhibitor, a new type of medication that “interferes with signals in the body that are thought to cause inflammation,” according to the American Academy of Dermatology Association. Within months of taking the medication, Maria Strattner’s hair started to regrow, according to her mom, who said of her daughter’s persistence, “Thank God that kid was smart enough not to give up.” Her mom Maryann Strattner told ABC News her daughter struggled both emotionally and physically with the loss of her hair. She said that together, they were determined to find a treatment that worked.

FDA-approved hair growth products include medications and therapies designed to treat different types of alopecia, such as alopecia areata and scarring alopecia. Alopecia areata is caused by an overactive immune system that attacks hair follicle cells. Hair loss typically occurs before age 40, and symptoms can range from periodically losing patches of scalp hair to the permanent loss of hair throughout the body. People with the autoimmune disease can experience hair loss anywhere on their body, including around the scalp, eyebrows and eyelashes, according to the American Academy of Dermatology.

FREE NEWSLETTER

  • Compared to traditional ADSC and ADSC-CM treatments, exosomes offer potential advantages, including being cell-free and less likely to provoke immune rejection 69.
  • To be sold under the brand name Olumiant by pharmaceutical company Eli Lilly, the drug has now satisfied the safety and efficacy requirements of the FDA, leading the agency to approve it as the first in-disease systemic treatment for alopecia areata.
  • Despite these promising developments, several challenges remain, including variability in patient response, delayed or non-response, relapse after discontinuation, and open questions regarding long-term safety.
  • Baricitinib was previously approved for treatment of rheumatoid arthritis, and its license was extended to the treatment of hospitalized COVID patients during the pandemic.
  • Hair growth products aim to counteract or neutralize those processes—but as with any long-term treatment, consistency is key to seeing results.

These options focus on promoting hair regrowth and treating different types of alopecia. A treatment for those with severe alopecia areata, an immune disorder that often results in hair loss, has been approved by the U.S. Olumiant is a JAK inhibitor and works by blocking the activity of one or more families of enzymes, and is not recommended for use with other drugs of this type.

It is the third FDA-approved medication to treat alopecia areata, which affects an estimated 700,000 Americans. Current treatments include steroids, minoxidil (the active ingredient in Rogaine and other hair growth products), and phototherapy. These treatments may be able to stimulate new hair growth in some people, but don’t necessarily prevent future hair loss, and they’re less effective for severe cases. In recent years, scientists fda approves first drug to treat hair loss caused by alopecia have been studying whether an existing class of drugs known as JAK inhibitors—including baricitinib—may be able to better block the aspects of the immune system that mistakenly attack hair follicles in these individuals.

The Food and Drug Administration approved the first-ever systemic treatment for adults with severe alopecia areata on Monday. A prospective trial involving 71 androgenetic alopecia (AGA) patients revealed nuanced therapeutic outcomes across treatment groups. Further studies confirm that ADSC-derived components enhance both hair thickness and density, particularly benefiting early-stage AGA progression 76. A subsequent series of animal and human investigations ultimately cemented the JAK-STAT pathway as a therapeutic target in AA.

Leave a Comment

Your email address will not be published. Required fields are marked *