‘The Need Is Huge’: FDA Approves First-Ever Drug For Alopecia
In clinical trials, Eli Lilly's once-daily pill, known as Olumiant, helped treated patients regrow much of their lost hair. And in Canada, health authorities approved Amylyx’s new drug, Albrioza, for amyotrophic lateral sclerosis, although the U.S. government says it needs more testing.
Stat:
Lilly Wins FDA Approval For Treatment For Hair Loss Caused By Autoimmunity
The Food and Drug Administration on Monday approved an Eli Lilly drug that is the first-ever treatment for alopecia areata, an autoimmune disorder that triggers sudden hair loss. The once-daily pill, known as Olumiant, was approved after clinical trials showed that treated patients regrew much of their lost hair. Patrik Jonsson, Lilly’s president of immunology, called the approval a historic moment for patients who until now have had to rely on cosmetic solutions, unapproved creams, and injections to manage the disease. (Wisen and Muthukumar, 6/13)
The New York Times:
F.D.A. Approves Alopecia Drug That Restores Hair Growth In Many Patients
The disease can vary in severity, but for some, it can be life-altering — a total loss of body hair, including eyelashes and eyebrows, even nose hair and hair in the ears. And, until recently, for those with alopecia areata, there was no treatment to make the hair grow back. But on Monday, the Food and Drug Administration approved baricitinib, a drug made by Eli Lilly that regrows hair by blocking the immune system from attacking hair follicles. Two other companies, Pfizer and Concert Pharmaceuticals, are close behind with similar drugs, known as JAK inhibitors. The drugs are already on the market for the treatment of rheumatoid arthritis and other autoimmune diseases. F.D.A. approval is important for insurance coverage of these expensive drugs, which have a list price of nearly $2,500 a month. (Kolata, 6/13)
And the FDA is under pressure to approve a new therapy for Lou Gehrig’s disease —
The Wall Street Journal:
Canada Approves Amylyx’s ALS Drug As U.S. Seeks More Time To Review
Canadian health authorities approved Amylyx Pharmaceuticals Inc.’s new drug for amyotrophic lateral sclerosis, the progressive neurodegenerative disease that robs patients of their ability to move and speak. It is the first Canadian approval since 2018 for a new drug treating the fatal condition, which is also known as Lou Gehrig’s disease. (Walker, 6/13)
The New York Times:
New Experimental Therapy For A.L.S. Approved In Canada
An experimental therapy for A.L.S., the paralyzing and fatal neurological disorder, has been approved in Canada, adding a new treatment option for a disease for which there are few effective therapies. The approval, the first in the world for the treatment — AMX0035, to be marketed in Canada as Albrioza — comes with the condition that the drug company later provide better evidence that the treatment works. (Belluck, 6/13)
In other pharmaceutical and research news —
The New York Times:
They Were Cigarette Smokers. Then A Stroke Vanquished Their Addiction.
Taking a scan of an injured brain often produces a map of irretrievable losses, revealing spots where damage causes memory difficulties or tremors. But in rare cases, those scans can expose just the opposite: plots of brain regions where an injury miraculously relieves someone’s symptoms, offering clues about how doctors might accomplish the same. A team of researchers has now taken a fresh look at a set of such brain images, drawn from cigarette smokers addicted to nicotine in whom strokes or other injuries spontaneously helped them quit. (Mueller, 6/13)
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A CRISPR Treatment For Blood Diseases Continues To Benefit Patients
an experimental, genome-editing treatment showed prolonged benefit for patients born with inherited blood disorders sickle cell disease and beta-thalassemia. Seventy-five patients have now been treated with the therapy developed jointly by Vertex Pharmaceuticals and CRISPR Therapeutics that uses CRISPR technology to genetically fix diseased cells. Following a one-time infusion, all 31 of the patients with sickle cell reported being free from episodes of severe pain; 42 of the 44 patients with beta-thalassemia no longer required blood transfusions. (Feuerstein, 6/11)
The New York Times:
Can Supplements Really Help With Depression Or Anxiety?
St. John’s wort “promotes a positive mood.” Valerian root reduces “levels of anxiety and stress.” Lavender oil is “calming for body and mind. ”If you are among the tens of millions of people in the United States who suffer from depression or anxiety, it is easy to be captivated by the promise of mood-boosting supplements. Take these pills daily, their marketing suggests, and soon you’ll be happily bouncing through verdant, sun-soaked fields, no prescription required. (Sneed, 6/13)
Stat:
Startup Gets Green Light To Use Apple Watch To Track Parkinson's Symptoms
Software that enables Apple Watch-based tracking of Parkinson’s disease symptoms has received clearance from the Food and Drug Administration, a move that could open doors for its maker as it strives to reach more people living with movement disorders — and potentially, those who haven’t developed them yet. The StrivePD system uses Apple’s Movement Disorder API to track tremors and dyskinetic symptoms of Parkinson’s from the Apple Watch. The data is all collected in an iPhone application, which allows patients to record their symptoms and keep tabs on medication. (Aguilar, 6/13)
