Until recently, people suffering from alopecia areata, a disorder that causes hair loss, had no treatment to regrow their hair, however, the U.S. Food and Drug Administration. The FDA has just approved a drug for alopecia that promises to end the suffering of adult patients.
Entering the shower and seeing how hundreds of hairs slip through your fingers while you rub yourself is one of the most painful moments for the more than 300,000 people who are affected by this condition in the United States each year, a disorder that can cause deep depression among those who suffer from it.
Thus, the FDA approved Eli Lilly Pharmaceuticals' Olumiant ?baricitinib? oral tablets to treat adult patients with severe alopecia areata. The action marks the agency's first approval of a systemic treatment--that is, it treats the entire body rather than a specific location--for the condition.
"Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia," said Kendall Marcus, director of the Division of Dermatology and Dentistry in the FDA's Center for Drug Evaluation and Research.
Alopecia areata, commonly known simply as alopecia, is an autoimmune disorder in which the body attacks its own hair follicles, causing hair to fall out, often in clumps.
Olumiant is a Janus kinase ?JAK? inhibitor that blocks the activity of one or more enzymes of a specific family, interfering with the pathway leading to inflammation.
The efficacy and safety of Olumiant in alopecia areata was studied in two randomized, double-blind, placebo-controlled trials in patients who had at least 50 percent scalp hair loss as measured by Alopecia Tool severity for more than six months.
Patients in these trials received either placebo, 2 milligrams of Olumiant or 4 milligrams of Olumiant every day. The primary efficacy measure for both trials was the proportion of patients who achieved at least 80 percent hair coverage by week 36 ?9 months?
While the drug has drawn tears and applause from patients, the most common side effects associated with Olumiant include: upper respiratory tract infections, headache, acne, high cholesterol - hyperlipidemia - increased creatinine phosphokinase enzyme, urinary tract infection and increased liver enzymes.
As well as inflammation of the hair follicles ?folliculitis?, fatigue , lower respiratory tract infections, nausea, genital candidiasis ?Candida infections?, anemia, low numbers of certain types of white blood cells ?neutropenia?, abdominal pain, shingles ?herpes zoster? and weight gain.
The use of Olumiant in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants is not recommended.
Olumiant comes with warnings and precautions that include the recommendation for close monitoring of the development of signs and symptoms of infection during and after treatment; evaluation of patients for active tuberculosis infection and testing for latent tuberculosis prior to treatment with Olumiant and the potential for viral reactivation.
In addition, other warnings and precautions include hypersensitivity - allergic reactions - gastrointestinal perforations - tears in the stomach or intestine - and laboratory abnormalities including low white and red blood cell counts, liver enzyme elevations and lipid elevations.
Olumiant comes with a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis.
The drug was originally approved in 2018 and has also been recommended as a treatment for certain adult patients with moderate to severe active rheumatoid arthritis, in addition to being approved for the treatment of COVID-19 in certain hospitalized adults.
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