Developers: | Eli Lilly & Company |
Branches: | Pharmaceuticals, Medicine, Health Care, Medical Device Manufacturers |
2022: Drug approved for baldness treatment
On June 13, 2022, the U.S. Food and Drug Administration (FDA) approved Olumiant oral tablets from Eli Lilly for the treatment of adult patients with severe alopecia. The disease, which often manifests itself in the form of baldness and annually affects more than 300 thousand people in the United States. The decision of the department is the first approval of systemic treatment, i.e. treatment of the entire body, and not a specific site, alopecia areate. Previously, Olumiant was used to treat coronavirus (COVID-19) infection.
Alopecia areata, commonly referred to simply as alopecia, is an autoimmune disorder in which the body attacks its own hair follicles, causing hair to fall out, often in whole clumps. An olumiant is a Janus kinase inhibitor that blocks the activity of one or more enzymes of a particular family, disrupting the pathway leading to inflammation.
The safety of Olumiant in alopecia areata has been investigated in two randomized, double-blind, placebo-controlled trials, Trial AA-1 and Trial AA-2, in patients whose scalp hair loss was at least 50%, according to to data the Severity of Alopecia Tool, for more than six months. Patients in these trials received either placebo or 2 mg of Olumiant or 4 mg each day. The primary efficacy measure in both trials was the proportion of patients achieving at least 80% scalp coverage at Week 36.
In the trial, AA-1 22% of 184 patients treated with 2 mg of Olumiant and 35% of 281 patients treated with 4 mg of Olumiant achieved adequate scalp coverage, compared with 5% of 189 patients treated with placebo. In the trial, AA-2 17% of 156 patients treated with 2 mg of Olumiant and 32% of 234 patients treated with 4 mg of Olumiant achieved adequate scalp coverage, compared with 3% of 156 patients treated with placebo.
The most common side effects associated with Olumiant include: upper respiratory tract infections, headache, acne, elevated cholesterol (hyperlipidemia), increased levels of the enzyme creatine phosphokinase, urinary tract infections, increased levels of liver enzymes, inflammation of hair follicles (folliculitis), fatigue, lower respiratory tract infections, nausea, genital yeast infections (Candida infections), anemia, low number of certain white blood cell types (neutropenia), abdominal pain, shingles (herpes zoster), and weight gain.
Olumiant is not recommended for use in combination with other inhibitors, biological immunomodulators, cyclosporine, or other strong immunosuppressants. Olumiant comes with warnings and precautions, including a recommendation to closely monitor the development of signs and symptoms of infection during and after treatment. It is recommended that patients be screened for active TB infection and tested for latent TB prior to starting treatment with Olumiant. Medical professionals should consider the possibility of reactivation of viruses.
Olumiant comes with a warning for serious infections, mortality, malignancies, major adverse cardiovascular events and thrombosis. The drug was originally approved in 2018 and entered the market as a treatment for some adult patients with moderately to severely active rheumatoid arthritis. Olumiant is also approved for the treatment of COVID-19 in some hospitalized adults.[1]