Health

F.D.A. Approves Alopecia Drug That Restores Hair Growth in Many Patients

The severity of the disease varies, but it can be life-changing. Hair may be completely lost, including eyelashes, eyebrows, and even nose and ear hair. And until recently, people with alopecia areata had no cure for their hair.

However On Monday, the Food and Drug Administration approved baricitinibA drug made by Eli Lilly, which regenerates hair by blocking the immune system from attacking hair follicles. Two other companies, Pfizer and Concert Pharmaceuticals, are just behind with a similar drug known as a JAK inhibitor. The drug is already on the market for the treatment of rheumatoid arthritis and other autoimmune diseases. FDA approval is important for insurance coverage of these expensive medicines, which have a list price of nearly $ 2,500 per month.

Lily’s drug was studied in two trials sponsored by the company Published in The New England Journal of Medicine last month, 1,200 patients with severe alopecia areata are involved. Almost 40% of those who took the drug showed complete or almost complete hair growth after 36 weeks. 1 year laterAlmost half of the patients have regained their hair.

Dr. Brett King, a professor of dermatology at Yale University, is a Principal Investigator for the two Lily exams and leads the exams sponsored by other companies. He said he was optimistic that the success rate of the drug would improve. Manufacturers may be able to improve JAK inhibitors for alopecia areata. And when all three companies have medicines on the market, patients who do not respond to one company’s medicines may respond to the other.

Patients in the Lily study experienced relatively mild side effects, including a slightly increased risk of acne, urinary tract infections, and other infections. These side effects were easily treated or ameliorated without treatment.

Lily’s trial results are “impressive,” wrote Dr. Andrew Messenger of the University of Sheffield and Matthew Harry’s of the University of Manchester. Ancillary editorial.. They added that the findings “represent the first published Phase 3 trial of treatment for this condition.”

According to the FDA, more than 300,000 Americans live with severe alopecia areata. The effects of this disease are difficult to exaggerate, Dr. King said.

For most people with alopecia areata, the disease manifests itself as one or several small bald spots on the head. But in severe cases it can be worse. One day you may notice a small bald spot on your head. After 3 months and even 3 weeks, there is no hair on the body.

Dr. King is widely acknowledged by his colleagues for being intrigued by the use of JAK inhibitors to treat alopecia areata. He said it all started when he noticed three summaries presented at the 2012 and 2013 medical conferences. A study led by Dr. Raphael Clynes and Dr. Angela Christiano of Columbia University involved mice, but showed that JAK inhibitors could reverse alopecia areata.

Shortly thereafter, a 25-year-old man named Kyle came to see Dr. King for the treatment of psoriasis. He had little hair and had large, red, scaly psoriatic plaques on his head and body.

“I saw him and said,’I have alopecia areata,'” said Dr. King.

Kyle wore a hat in a high school dance and began to notice terrible hair loss. He went to the bathroom, took off his hat, and scaredly found a lot of hair in his hat.

“It’s an episode of the Twilight Zone,” said Dr. King.

He looked at Kyle and said, “If you want to try something wild that has never been done before, there are medicines approved for rheumatoid arthritis and developed for psoriasis. That works well. There are some suggestions for mice that may go. “

Kyle agreed to take tofacitinib, a JAK inhibitor similar to Pfizer’s Lily drug. Eight months later, he restored his hair.

After Dr. King Published the report At Kyle, other dermatologists have begun trying JAK inhibitors.

Dr. Marianne McLedessena, director of the Hair Removal Center of Excellence in Beth Israel Lahei Health, Massachusetts, was one of them.

She wins the insurance company to cover the drug and will sometimes succeed.

“It’s great to see the amazing impact,” said Dr. Senna, who received consulting fees from Eli Lilly and Pfizer. “They come without hair and completely withdraw from life. Their eyes are depressed. They come back and say,” I have regained my life. I have regained myself. increase.”

Dr. Natasha Atanaskova Mesinkovska, Chief Scientific Officer of the National Alopecia Areata Foundation and Professor of Dermatology at the University of California, Irvine, helped pharmaceutical companies find patients for the trial. She was also impressed with the results of those who responded to the drug.

Severe hair loss is not only a “deprivation of a person’s identity” but also a “medical problem,” she said, adding that loss of hair in the nose and ears affects allergies and hearing.

Christian Daniels, a 27-year-old data center engineer in Peoria, Illinois, said hair loss also affected his eyes. Without eyelashes, dust could get in my eyes and get frustrating, so I started putting petrolatum on my eyelids.

Daniels’ hair began to fall out at the age of 25. Within a month, all his hair was gone.

He said Covid-19 was a “disguise blessing” because he was able to work from home.

“I felt like my life was stagnant,” he said. “I felt that the only thing that matters was how to get my hair back.”

He found Lily’s trial by “Google and Google”.

Now he said, “It seems like it rarely happened,” but he still sometimes has flashbacks when he looks in the mirror and remembers himself hairless.

Dr. Brittany Craiglow, a private practitioner in Fairfield, Connecticut, who is married to Dr. King, said severe alopecia areata is particularly difficult for children.

A patient, Cassidy McWell, Canton, Massachusetts, lost her hair when she was eight. When her adult saw her, they thought she had her cancer.

“When we’re in a restaurant where we’re having dinner, people will come to Cassidy,” said her mother, Melissa McWell. Some even try to pay for meals. “They will hug her and say,’I’m sorry. I’ll keep fighting.'”

Brooke Nelson, one of Dr. Craiglow’s patients in Belleville, NJ, lost all his long blonde hair in his first year. Brooke was so embarrassed about her hair loss that her mother, Daniel Nelson, homeschooled her.

She took Brooke to the medical center after the medical center and to the doctor after the doctor, but it didn’t help. “If that meant returning her hair to Brooke, I would have given up my house and gave up everything,” Nelson said.

Nelson was ready to take Brooke to China for stem cell therapy when he found Dr. Craiglow, who gave Brooke a JAK inhibitor. Her hair has returned to normal.

“It was a miracle,” Nelson said.

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