Drug to treat alopecia approved by FDA
Olumiant is also used to treat certain adult patients with moderately to severely active rheumatoid arthritis
The Food and Drug Administration (FDA) said Tuesday that adults with severe alopecia areata can take Olumiant tablets by mouth.
This is the first time that the FDA has approved a treatment for the disorder that works all over the body.In a statement, Dr. Kendall Marcus, head of the FDA's Division of Dermatology and Dentistry and director of the Center for Drug Evaluation and Research, said that people with severe alopecia must have access to safe and effective treatments. "Today's approval will help patients with severe alopecia areata meet a big unmet need." The Food and Drug Administration (FDA) said Tuesday that adults with severe alopecia areata can take Olumiant tablets by mouth.
This is the first time that the FDA has approved a treatment for the disorder that works all over the body.In a statement, Dr. Kendall Marcus, head of the FDA's Division of Dermatology and Dentistry and director of the Center for Drug Evaluation and Research, said that people with severe alopecia must have access to safe and effective treatments. "Today's approval will help patients with severe alopecia areata meet a big unmet need."
Alopecia areata, which most people just call "alopecia," is an autoimmune disorder that causes hair loss anywhere on the body when the body attacks its own hair follicles.The American Academy of Dermatology Association says it can start at any age, but most people get it when they are young or in their teens.There are different kinds of alopecia areata, such as alopecia totalis and alopecia universalis.
More than 300,000 Americans get this disorder every year, and it often looks like patchy baldness
Eli Lilly got the green light to sell the drug.The tablets are a Janus kinase (JAK) inhibitor, which stops one or more enzymes in a certain family from doing their job. This blocks the path that leads to inflammation.
Two randomised, double-blind, placebo-controlled trials were done to test how well it worked and if it was safe.The severity of alopecia tool showed that participants had lost at least 50% of their scalp hair for more than six months.
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Every day, the patients were given either a placebo, 2 milligrammes of Olumiant, or 4 milligrammes.The FDA said that the number of patients who had at least 80% scalp hair coverage at week 36 was the main way to measure the effectiveness of both trials.
"In Trial AA-1, 22% of the 184 patients who got 2 milligrammes of Olumiant and 35% of the 281 patients who got 4 milligrammes of Olumiant had enough hair on their scalps. Only 5% of the 189 patients who got a placebo had enough hair on their scalps. In Trial AA-2, 17 percent of the 156 patients who got 2 milligrammes of Olumiant and 32 percent of the 234 patients who got 4 milligrammes of Olumiant had enough hair on their scalps. Only 3 percent of the 156 patients who got 1 milligramme of Olumiant had enough hair on their scalps "who got a fake drug instead," the FDA said.
Most people who take Olumiant get upper respiratory tract infections, headaches, acne, high cholesterol, tiredness, nausea, and gain weight.It was first approved in 2018 to treat certain adults with moderately to severely active rheumatoid arthritis. It is also approved to treat COVID-19 in certain adults who are hospitalised.It shouldn't be used with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other strong immune system suppressants.
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