Drug That Restored Hair In 80 Per Cent Of Baldness Cases In Trials Is Approved

A new drug that allegedly restored hair in 80 per cent of baldness cases has been approved by the US Food and Drug Administration (FDA).

Alopecia areata is an autoimmune disease that causes patchy hair loss on the scalp, face, and sometimes other areas of the body. It affects both men and women and can occur at any age.

As published in April 2023 by the scientific journal The Lancet, in its clinical trials, this new oral drug from the Pfizer laboratory presented ‘excellent results’. It has now been approved for the treatment of severe alopecia areata (AA), as reported by larazon.es.

The drug will go by the name Litfulo

The drug, Ritlecitinib, will be sold under the brand name Litfulo. For now, it is the first and only treatment approved by the FDA for adolescents older than 12 years with the disease.

Angela Hwang, Pfizer’s chief commercial officer and president of global biopharmaceuticals said: ‘Litfulo is a major advance in the treatment of alopecia areata, an autoimmune disease that previously had no FDA-approved options for adolescents and limited options available for adults’.

‘With the drug’s approval, adolescents and adults struggling with substantial hair loss have the opportunity to achieve significant scalp hair growth’, she added.

Alopecia areata can develop at any age in young people

Although patients can start to develop symptoms of alopecia areata at any age: ‘most people start showing signs in their teens, 20s or 30s’, explained Brittany Craiglow, an associate professor of dermatology at the School of Medicine, from Yale.

He added: ‘Litfulo is a particularly important treatment option for younger patients with significant hair loss, who often battle such visible disease’.

Clinical trials involved 718 patients from 18 countries

Clinical trials of the drug included the participation of 718 patients with alopecia areata from 18 countries. They were divided into two groups. The first one would consume 50 milligrams of the drug per day and the other a simple placebo.

In total, 23 per cent of the patients treated with the drug over a six-month period had up to 80 per cent hair growth. That was compared with only 1.6 per cent of those administered the placebo.

According to the study results, patients who had had the disease for longer had worse outcomes. This suggested that the drug was more effective in the early stages.

The efficacy and safety of the drug were consistent among adolescents 12 to 17 years of age and adults 18 years and older.

How does the drug work?

In mouse models and scalp biopsy studies it was shown to dampen the body’s overactive immune response.

What side effects can it have?

The most common adverse events reported in at least 4 per cent of patients treated with Litfulo included headache (10.8 per cent), diarrhoea (10 per cent), acne (6.2 per cent), rash (5.4 per cent), and urticaria (4.6 per cent).