Promising drug promotes hair growth in half of study participants

From Staff Reports

The U.S. Food and Drug Administration has approved a new oral medication designed to treat adults with severe alopecia areata. It marks the first FDA approval of a systemic treatment — treats the entire body rather than a specific location — for alopecia areata.

Dr. Kendall Marcus

Dr. Kendall Marcus

“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” Dr. Kendall Marcus, director of the Division of Dermatology and Dentistry in the FDA’s Center for Drug Evaluation and Research, said in an FDA news release.

The approval, she said, “will help fulfill a significant unmet need for patients with severe alopecia areata.”

The drug, Olumiant, works to block the activity of one or more of a specific family of enzymes, interfering with the pathway that leads to inflammation and, ultimately, hair loss.

Olumiant was studied in two groups in controlled trials with patients who had at least 50% loss of scalp hair 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 FDA said in its release. “The primary measurement of efficacy for both trials was the proportion of patients who achieved at least 80% scalp hair coverage at week 36.”

Dr. Brett King

In one of the studies, 22% of 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 the second trial, “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 FDA reported.

“People with alopecia areata, dermatologists and other health care providers have been looking forward to this day when there is an FDA-approved systemic medicine for this often-devastating disease,” said Dr. Brett King, an associate professor of dermatology at Yale School of Medicine and a lead investigator in the clinical trials.

Alopecia areata causes unpredictable hair loss that can be patchy or complete, and it affects people of all ages and ethnicities,” he said. “I am so happy that adults with severe alopecia areata can now take OLUMIANT, a once-daily pill. The results of clinical trials are remarkable, as one in five adults taking OLUMIANT 2-mg/day and one in three taking OLUMIANT 4-mg/day achieved significant hair regrowth resulting in 80% or more scalp coverage, and eyebrow and eyelash improvements were also achieved for patients taking OLUMIANT 4-mg/day with substantial eyebrow or eyelash hair loss.”

Before and after images of four study participants who received 36 weeks of treatment for severe alopecia areata with the drug baricitinib. Brett King/Yale School of Medicine

The FDA warned that common side effects include upper respiratory tract infections, headache, acne, high cholesterol, increase of an enzyme called creatinine phosphokinase, urinary tract infection, liver enzyme elevations, inflammation of hair follicles, fatigue, lower respiratory tract infections, nausea, genital yeast infections, anemia, low number of certain types of white blood cells, abdominal pain, shingles and weight gain.  

Other Medications for Alopecia from

  • Spironolactone
  • Minoxidil
  • Azulfidine
  • Sulfasalazine
  • Aldactone
  • Rogaine
  • Kenalog-10
  • Triamcinolone
  • Rogaine Men’s Extra Strength
  • Aristospan
  • Rogaine Women’s
  • Hair Regrowth Treatment for Women
  • Kenalog-40
  • Hair Regrowth Treatment for Men
  • Azulfidine EN-tabs
  • Baricitinib