Monday’s approval by the Food and Drug Administration of a drug called Baricitinib was the first to treat severe alopecia areata. This is an autoimmune disorder that affects more than 300,000.
Alopecia can cause temporary or permanent hair loss. It can also affect any hair-bearing area of the body. This can lead to emotional distress. Recent high-profile cases such as Jada Pinkett Smith, actress in Hollywood, and Rep. AyannaPressley have brought attention to this condition.
Kendall Marcus, an FDA official, stated that “access to safe and effective treatments is vital for the significant number Americans affected by severe hair loss.” “Today’s approval will fulfill a significant unmet medical need for patients suffering from severe alopecia areata.”
Baricitinib is a drug that belongs to the Janus kinase inhibitions class. It is manufactured by U.S. pharmaceutical giant Eli Lilly. It interferes with the cellular pathway leading to inflammation.
According to the New York Times, Pfizer and Concert Pharmaceuticals are “close behind” with similar drugs.
Two controlled, randomized clinical trials that included 1,200 patients with severe alopecia led to its approval.
Participants were divided into three groups in each trial: a placebo, a two-milligram daily dose, and a four-milligram daily dose.
Nearly 40% of patients on the higher dose had their hair back after 36 weeks. This compares to approximately 23 percent in the lower dose and just five percent in the placebo group.
A significant amount of eyebrow and eyelash growth was also seen in those who took higher doses.
Side effects include headaches, upper respiratory tract infections and high cholesterol.
Topical and oral medications were used in the past for alopecia. However, these treatments were experimental and not approved.
Baricitinib had been approved previously for the treatment of rheumatoid arthritis. During the pandemic, its license was extended to hospitalized COVID patients.
The Times notes that FDA approval is important in getting insurance companies covered for drug costs. They also point out that Janus kinase inhibits have a list cost of almost $2,500 per month.