Promising Results

The US Food and Drug Administration has approved a new drug that restores 80% of hair in people with alopecia.

A recent randomized, double-blind clinical trial of the drug showed such promising results, and the US Food and Drug Administration (FDA) has just approved its use for patients 12 years of age and older.

What is Alopecia?

Alopecia areata is characterized by hair loss on the head, face, or body. It occurs when a person’s immune system starts attacking a person’s hair follicles, and while most patients are otherwise healthy, incomplete or complete hair loss can have severe mental and emotional consequences.

In some patients with severe forms of the disease, all the hair on the head, eyelashes, eyebrows, as well as all the hair on the body falls out – a condition known as universal alopecia. Such severe cases tend to be particularly resistant to available treatments, but a new drug called rtilecitinib could help change that.

Effective Treatment

In phase II and III clinical trials, the drug reversed up to 80% of scalp hair loss in almost a quarter of all patients, and still appears to be one of the few effective treatments for severe alopecia areata. Its approval also makes it the only treatment available for children.

Another oral drug for alopecia areata, baricitinib, was approved by the FDA in 2022 for adults only. It works about 20% of the time at the recommended dose.

New Alternative

In the coming weeks, rtlecitinib will be available to patients as a much-needed alternative. It is sold by Pfizer under the brand name LITFULO™ and the recommended dose is 50 milligrams per day.

“LITFULO is an especially important treatment option for young patients with significant hair loss, who often suffer from this visible condition,” Yale University dermatologist Brittany Craiglow, MD, said in a Pfizer press release.

Clinical Trials

More than 700 patients with alopecia areata from 18 countries participated in the latest LITFULO clinical trial. Each participant experienced hair loss on half of the head for less than ten years, and half of the group experienced complete hair loss on the head.

Compared to those taking placebo, patients taking 50 milligrams of LITFULO daily experienced significant hair growth. Overall, about 23% of patients taking the drug for six months showed 80% or more scalp coverage compared to 1.6% of patients taking placebo.

Mechanism of Action

The exact way in which LITFULO reverses hair loss and promotes hair growth is still unknown, but in mouse models and scalp biopsy studies, it appears to attenuate the body’s overactive immune response.

As an enzyme inhibitor, the drug prevents immune cells from triggering a specific signaling pathway that can cause inflammation in hair follicles.

The hair growth seen in clinical trials suggests that these hair follicles can be restored, possibly restoring their “immune privileges”.

Side Effects

Unfortunately, this mechanism of action can interfere with the normal function of the immune system, meaning that patients taking LIFULO may be more susceptible to infections and disease.

In the current clinical study, side effects were considered minimal and manageable.

Conclusion

The study was published in The Lancet. Source: Science Alert