Agency Approves First Pill For Alopecia Treatment In 2022

First Pill For Alopecia Treatment Approved In 2022

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The Food and Drug Administration on Monday approved the first pill for alopecia in 2022.

A drug called Baricitinib was approved as the first oral tablet for treating severe alopecia areata.

What is Alopecia Areata?

Alopecia areata is an autoimmune disorder affecting more than 300,000 people in the United States yearly.

It causes either temporary or permanent patchy hair loss. This usually affects any hair-bearing site of the body, leading to emotional distress. The condition has come to the fore recently through high-profile cases including Hollywood actress Jada Pinkett Smith and congresswoman Ayanna Pressley.

The FDA Official, Kendall Marcus said in a statement:

“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia. 

“Today’s approval will help fulfil a significant unmet need for patients with severe alopecia areata.”

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Baricitinib is made by US pharmaceutical company Eli Lilly and known by the trade name Olumiant. It belongs to a class of drugs called Janus kinase inhibitors. Baricitinib works by modulating the cellular pathway that leads to inflammation.

Its approval for use against alopecia resulted from two randomized, controlled clinical trials. The trials involved a total of 1,200 adults with severe alopecia.

Each trial split participants into three groups:

1. A placebo group.
2. A group that received a two-milligram dose every day.
3. A group that received a four-milligram dose every day.

After 36 weeks, almost 40 per cent of those on the higher dose grew back 80 per cent of their scalp hair.

The lower dose group grew by about 23 per cent while the placebo group grew by five per cent.

Also, 45 per cent of people in the higher dose group also saw remarkable eyebrow and eyelash regrowth.

The most common side effects include:

• Upper respiratory tract infections.
• Headaches.
• Acne.
• High cholesterol.
• An increase in an enzyme called creatine phosphokinase.

In the past, there have been experimental drugs for alopecia and they were also not approved. These drugs are:

• Topical drugs.
• Oral Drugs.

Baricitinib was previously approved for the treatment of rheumatoid arthritis. Also, during the COVID-19 pandemic, its license was extended to the treatment of hospitalized Covid patients.

Source: PUNCH HealthWise