The FDA has approved the first treatment for severe alopecia: what it is and how it is used

According to the FDA, alopecia areata affects more than 300,000 people in the United States alone (Getty)

This Monday, US Food and Drug Administration (FDA)for its acronym in English) approved First systemic treatment of severe alopecia areata. The drug, which received the approval of the North American organization, is Olumiant (baricitinib)which is administered in tablet form for oral administration and is intended for the adult population.

A few months ago, alopecia areata made headlines after the American actor Will Smith Goalkeeper and Chris Rock, during the delivery of 2022 Oscarsafter the comedian made a “joke” about the disease suffered by actress Jada Pinkett Smiththe musician’s wife. Today, with this announcement, the artist’s illness could be over.

In this sense, Kendall Marcus, Director of Dermatology and Dentistry at the FDA Center for Drug Evaluation and Research“Access to safe and effective treatment options is crucial for a significant number of Americans affected by severe alopecia.” “Today’s approval will help fill a significant unmet need for patients with severe alopecia areata.”he added.

During the 2022 Oscars, Will Smith hit Chris Rock after a
During the 2022 Oscars, Will Smith hit Chris Rock after a “joke” against his wife, Jada Pinkett Smith (Photo: Instagram)

According to the FDA, Severe alopecia areata (also known as alopecia) is a disease which generally manifests as spotty baldness. This is a disease autoimmune; It is the body attacks its own hair follicles, causing hair loss, even lumps. in the United States only, This disease affects more than 300,000 people each year.

In the last hours, the health authority approved the first systemic treatment (meaning it treats the whole body instead of a specific place) for alopecia areata. The drug that has been approved by the North American Health Organization is Olumiant, “Janus kinase inhibitor (JAK), which blocks the activity of one or more enzymes from a specific family, obstructs the pathway that leads to inflammation”They noted in a statement.

The FDA also explained the reasons for the approval and noted that “the efficacy and safety of Olumiant in alopecia areata have been studied in two randomized, double-blind, placebo-controlled studies (AA-1 and AA-2 trials) with patients who had at least 50% hair loss on the scalpmeasured by the severity of the alopecia instrument, for more than six months.

To test the effectiveness of this drug, the researchers conducted a study in which volunteers were divided into three groups, in two of which they were given different doses of the recently approved drug (Getty).
To test the effectiveness of this drug, the researchers conducted a study in which volunteers were divided into three groups, in two of which they were given different doses of the recently approved drug (Getty).

To determine its effectiveness, the researchers divided the volunteers into three groups: placebo, 2 milligrams Olumiant and 4 milligrams Olumiant. Patients took these proportions of the drug daily and the main measure of effectiveness was “Percentage of patients who achieved at least 80% scalp hair coverage at 36 weeks.

“In study AA-1, 22% of 184 patients who received 2 milligrams of Olumiant and 35% of 281 patients who received 4 milligrams of Olumiant achieved adequate scalp hair coverage compared to 5 milligrams of Olumiant. % of 189 patients who received placebo. In study AA-2, 17% of 156 patients who received 2 milligrams of Olumiant and 32% of 234 patients who received 4 mg of Olumiant achieved adequate scalp hair coverage, compared with 3% of 156 patients who received who received a placebo, ”they listed by the FDA.

Between the most common side effects related to this medicine, the health authority indicated: upper respiratory tract infections, headache, acne, high cholesterol (hyperlipidemia), increased enzyme called creatinine phosphokinase, urinary tract infection, elevated liver enzymes, inflammation of hair follicles (folliculitis), fatigue, infections, infections lower respiratory tract, genital candidiasis (Candida infections), anemia, low white blood cell count (neutropenia), abdominal pain, shingles (shingles) and weight gain.

This is the first systemic treatment for alopecia areata before it is given topically (Getty Images)
This is the first systemic treatment for alopecia areata before it is given topically (Getty Images)

It is worth clarifying that the FDA does not recommend the use of the drug “in combination with other JAK inhibitors, biological immunomodulators, cyclosporine or other potent immunosuppressants”. “Olumiant comes with a box of warning of serious infections, mortality, malignancies, major adverse cardiovascular events and thrombosis“, Stressed the health person.

Olumiant comes with warnings and precautions that include a recommendation to closely monitor the development of signs and symptoms of infection during and after treatment.; assessment of patients for active tuberculosis infection and testing for latent tuberculosis before treatment with Olumiant; and the ability to reactivate the virus. In addition, other warnings and precautions include hypersensitivity (allergic reactions), gastrointestinal perforations (ruptures of the stomach or intestines) and laboratory abnormalities, including low white and red blood cell counts, elevated liver enzymes and increased lipids. ” they conclude.FDA experts.

CONTINUE READING:

Alopecia: what is the disease suffered by the wife of Will Smith and for which caused a quarrel at the full delivery of the Oscars 2022
What is alopecia, what causes it and how to avoid it
Hair loss: 6 scientifically supported treatments in the world

Leave a Comment