FDA Approves New Drug For Alopecia Areata—Olumiant (Baricitinib)

The U.S. Food and Drug Administration approved a new drug to treat alopecia areata, a common autoimmune disease that causes patchy hair loss. The disease affects more than 300,000 people in the United States each year.

The drug, Olumiant (baricitinib), made by Eli Lilly, is an oral tablet that is taken once daily. This drug was approved in 2018 for severely active rheumatoid arthritis and recently lifted a new indication to treat hospitalized COVID-19 patients. Eli Lilly’s applied at the end of 2021 with alopecia as one possible indication; they hope this will help regrow hair. 

The drug is thought to work by inhibiting the Janus kinase (JAK) enzymes, which are involved in the signalling of immune cells.

However, other companies are also close behind with similar drugs. For example, Pfizer and Concert Pharmaceuticals have JAK inhibitors that could be alternatives for those who cannot afford Olumiant or don’t want to take it. 

new drug for alopecia
new drug for alopecia

In clinical trials, the drug was effective in treating patients with severe alopecia areata.

The most common side effects of the drug include headache, shortness of breath, chest pain, lightheadedness, diarrhea, and upper respiratory tract infection. The FDA has also advised that the drug may increase the risk of severe conditions and blood clotting. However, the drug’s benefits may outweigh the risks for patients with severe alopecia areata who have not responded to other treatments.

The efficacy and safety of Olumiant in Alopecia were studied in two randomized, double-blind trials with patients with at least 50% scalp hair loss measured by the Severity Alopecia Tool for over six months. Patients receiving either a placebo or 2 or 4 milligrams per day experienced an improvement in their symptoms. 

The drug was tolerated well, but in a few cases, it causes a small increased risk of acne, urinary tract infections, and other infections. These are not severe side effects and can be treated easily. Other rare but serious side effects include tuberculosis (TB), shingles, and others caused by bacteria, fungi, or viruses. 

Olumiant is a highly effective medicine that comes with warnings and precautions. It’s essential to closely monitor patients during treatment for signs or symptoms of infection and after they’ve finished taking Olumiant. Strictly avoid concurrent use with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants. 

Also, don’t use it if you have a hypersensitivity reaction. Avoid it in case of gastrointestinal perforations, low white and red blood cell counts, liver enzyme elevations, and lipid elevations.

Olumiant Mechanism

Olumiant® is a medication that functions by inhibiting the activity of selective JAK1 and 2 enzymes, which interfere with cellular signals in our bodies known as cytokines. Cytokine regulation is essential in regulating cell growth or immune response for any given organism’s survival tactics against outside forces.

Olumiant is a potential new treatment that can help patients with scalp hair loss because it blocks the activity of enzymes that causes inflammation. In clinical trials, those who had at least 50% of their head covered achieved 80% or greater by the end of 36 weeks of treatment. 

Olumiant Cost

Olumiant can be expensive, but prices vary depending on your insurance plan. The list price of Olumiant is $2,497 for 30 days worth (2 mg) at a time – no need to worry about interrupting treatment if you run out. 

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