The US Food and Drug Administration (FDA) has approved the first oral tablet to counter alopecia areata, the health authority annoucned on 13 June.
A statement released by the US FDA said that the drug, baricitinib, sold under the brand name of Olumiant, is an oral tablet that has been approved to treat severe alopecia areata in adult patients.
Alopecia areata is an autoimmune disorder that results in patchy hairloss. In some cases it can lead to a total loss of both head and body hair, and until now there was no treatment for it.
Although alopecia itself doesn't cause a threat to one's health, it can take a toll on one's mental health.
Many celebrities, including Hollywood actress Jada Pinkett Smith, have been vocal about their struggle with alopecia related hair loss in an attempt to garner public awareness and empathy towards people with the condition, who are often stigmatised and ridiculed, and experience body image issues.
"Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata."Kendall Marcus, M.D., Director, Division of Dermatology and Dentistry, FDA’s Center for Drug Evaluation and Research
How much do we know about this treatment? FIT answers your FAQs.
Who is producing it?
Olumiant has been developed and is being produced by US based pharmaceutical company Eli Lilly and Company.
How does it work?
People with alopecia areata lose hair – often in lumps – because the autoimmune condition causes their body to attack their hair follicles.
The way Olumiant works is by blocking the activity of one or more of a specific family of enzymes, interfering with the pathway that leads to inflammation, explained the FDA.
To be more precise, Olumiant is a Janus kinase (JAK) inhibitor.
What did the clinical trials find?
Two randomised, double-blind, placebo-controlled trials were conducted to determine the safety and efficacy of the drug.
In both trials, participants included patients with 50 percent scalp hair loss as measured for more than six months.
In both the trials, the participants were divided into three groups - those who received 2 milligrams of Olumiant, those who got 4 milligrams of Olumiant, and those who received placebo.
After 36 weeks, in the first trial,
22 percent of the 184 patients who received 2 milligrams of Olumiant achieved at least 80 percent scalp hair coverage
35 percent of the 281 patients who received 4 milligrams of Olumiant achieved adequate scalp hair coverage.
5 percent of the 189 patients who received a placebo received the same level of hair coverage.
In the second trial,
17 percent of the 156 patients who received 2 milligrams of Olumiant achieved at least 80 percent scalp hair coverage
32 percent of the 234 patients who received 4 milligrams of Olumiant achieved adequate scalp hair coverage
3 percent of the 156 patients who received a placebo saw similar hair growth.
Are there any side effects of the drug?
In the clinical trials, the most common side effects that were noted were,
Upper respiratory tract infections
Headache
High cholesterol (hyperlipidemia)
Increase of an enzyme called creatinine phosphokinase that can increase the risk of urinary tract infections, and kidney stones
Inflammation of hair follicles (folliculitis)
Fatigue
Lower respiratory tract infections
Nausea
Genital yeast infections
Weight increase.
Apart from these, according to the US FDA, Olumiant also comes with a boxed warning for serious infections, mortality, major adverse cardiovascular events and thrombosis.
Is it a new drug?
No, although this is the first time the drug has been tested in, and approved for the treatment of alopecia areata, it has been around for a few years now.
Olumiant was first approved in 2018 for the treatment of rheumatoid arthritis.
Is it available in India?
The drug Olumiant meant for rheumatoid arthritis is available in India.
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