The Food and Drug Administration (FDA) approved a drug called baricitinib as the first for treating severe alopecia areata, an autoimmune hair loss disorder affecting more than 300,000 people in the United States every year.
Alopecia causes either temporary or permanent patchy hair loss that can affect any hair-bearing site of the body, leading to emotional distress. The condition has come to the fore recently through high-profile cases including Hollywood actress Jada Pinkett Smith and Rep. Ayanna Pressley.
“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” said FDA official Kendall Marcus in a statement. “Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata.”
Baricitinib, which is made by U.S. pharmaceutical company Eli Lilly and known by the trade name Olumiant, belongs to a class of drugs called Janus kinase inhibitors. It works by interfering with the cellular pathway that leads to inflammation.
The New York Times says Pfizer and Concert Pharmaceuticals “are close behind with similar drugs.”
Its approval for use against alopecia was based on the results of two randomized, controlled clinical trials involving a total 1,200 adults with severe alopecia.
Each trial split participants into three groups: a placebo group, a group that received a two-milligram dose every day, and a group that received a four-milligram dose every day.
After 36 weeks, almost 40 percent of those on the higher dose grew back 80 percent of their scalp hair, compared to around 23 percent of the lower dose group, and five percent of the placebo group.
Around 45 percent of people in the higher dose group also saw significant eyebrow and eyelash regrowth.
The most common side effects included upper respiratory tract infections, headaches, acne, high cholesterol, and increase of an enzyme called creatine phosphokinase.
Prior treatments for alopecia included topical or oral drugs, but these have been considered experimental and none was approved.
Baricitinib was previously approved for treatment of rheumatoid arthritis, and its license was extended to the treatment of hospitalized COVID patients during the pandemic.
The Times points out that FDA approval plays an important role in getting insurance companies to cover the costs of drugs, adding that Janus kinase inhibitors have a list price of nearly $2,500 a month.
“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” said Kendall Marcus, M.D., director of the Division of Dermatology and Dentistry in the FDA’s Center for Drug Evaluation and Research. “Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata.”
Alopecia areata, commonly referred to as just 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 which blocks the activity of one or more of a specific family of enzymes, interfering with the pathway that leads to inflammation.
The efficacy and safety of Olumiant in alopecia areata was studied in two randomized, double-blind, placebo-controlled trials (Trial AA-1 and Trial AA-2) with patients who had at least 50% scalp hair loss as measured by the Severity of Alopecia Tool for more than six months. Patients in these trials received either a placebo, 2 milligrams of Olumiant, or 4 milligrams of Olumiant every day. The primary measurement of efficacy for both trials was the proportion of patients who achieved at least 80% scalp hair coverage at week 36.
In Trial AA-1, 22% of the 184 patients who received 2 milligrams of Olumiant and 35% of the 281 patients who received 4 milligrams of Olumiant achieved adequate scalp hair coverage, compared to 5% of the 189 patients who received a placebo. In Trial AA-2, 17% of the 156 patients who received 2 milligrams of Olumiant and 32% of the 234 patients who received 4 milligrams of Olumiant achieved adequate scalp hair coverage, compared to 3% of the 156 patients who received a placebo.
The most common side effects associated with Olumiant include: upper respiratory tract infections, headache, acne, high cholesterol (hyperlipidemia), increase of an enzyme called creatinine phosphokinase, urinary tract infection, liver enzyme elevations, inflammation of hair follicles (folliculitis), fatigue, lower respiratory tract infections, nausea, genital yeast infections (Candida infections), anemia, low number of certain types of white blood cells (neutropenia), abdominal pain, shingles (herpes zoster) and weight increase.
Olumiant is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants. Olumiant comes with warnings and precautions including recommending close monitoring for the development of signs and symptoms of infection during and after treatment; evaluating 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 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.
Olumiant received priority review and breakthrough therapy designations for this indication.
Olumiant was originally approved in 2018. It is approved as a treatment for certain adult patients with moderately to severely active rheumatoid arthritis. Olumiant is also approved for the treatment of COVID-19 in certain hospitalized adults.
The FDA granted the approval of Olumiant to Eli Lilly and Company.