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FDA Approval- Lilly And Incyte's "OLUMIANT" As First Systemic Medicine For Adults With Severe Alopecia

Author: Medical Team (Alniche Life Sciences)


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The prevalence of Alopecia Areata increased from 2016 to 2019, which is 60% more among females than among males and higher among adults than among children.

Eli Lilly and Company and Incyte on June 13 2022, announced that the U.S. Food and Drug Administration (FDA) has approved OLUMIANT (baricitinib), once a daily pill, as a first-in-disease systemic treatment for adults with severe alopecia areata (AA).


Indications and Usage

OLUMIANT is indicated for the treatment of adult patients with severe alopecia areata, moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers.

Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying anti rheumatic drugs (DMARDs), or with potent immunosuppressant such as azathioprine and cyclosporine.

OLUMIANT is indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

The treatment dose is available as 4-mg, 2-mg and 1-mg tablets. The recommended dose is 2-mg/day, with an increase to 4-mg/day if results are not inadequate.

For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider treating with 4-mg/day. Once an adequate response is achieved on 4-mg/day, the dosage is to be decreased to 2-mg/day.

The results of clinical trials are very positive, 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% positive results, and eyebrow and eyelash improvements were also achieved for patients taking OLUMIANT 4-mg/day.

The approval was based on BRAVE-AA1 and BRAVE-AA2 trials, the largest Phase 3 AA clinical trial program.

11-13% of patients taking OLUMIANT 2-mg/day and 24-26% of patients taking OLUMIANT 4-mg/day achieved 90% or more hair coverage, compared to 1-4% of patients taking placebo; results for OLUMIANT 2-mg/day were not statistically significant under the multiplicity control plan for BRAVE-AA2. Among patients with substantial eyebrow and eyelash hair loss at baseline, improvements in eyebrow and eyelash coverage were seen for patients taking OLUMIANT 4-mg daily at 36 weeks.

Few patients discontinued treatment due to adverse events (average of 2.2% across both studies) in the 36-week placebo-controlled period and the majority of treatment-emergent adverse events were mild or moderate in severity.

The most commonly reported adverse reactions (≥1%) were upper respiratory tract infections, headache, acne, high cholesterol levels, increases in blood markers related to the muscle, urinary tract infections, increased liver enzyme levels, inflammation, fatigue, genital yeast infection, low blood cell counts, abdominal pain, shingles and weight increase.

"Today marks a milestone with the first-ever FDA-approved systemic treatment for alopecia areata patients, which include limited public knowledge about the disease", said Nicole Friedland, president and chief executive officer, National Alopecia Areata Foundation (NAAF). "Our mission is to make life better for people living with debilitating immune-mediated diseases. OLUMIANT's approval is a historic moment, and we're delighted about what it can mean for adults with severe alopecia areata.

Serious Infections

Most patients with Rheumatoid Arthritis (RA) who developed these infections were taking concomitant immunosuppressant such as methotrexate or corticosteroids. If a serious infection develops, stop the treatment until the infection is controlled.

Reported infections include: Active tuberculosis (TB), which may present with pulmonary or extra pulmonary disease, fungal infections.

Common serious infections reported are pneumonia, herpes zoster, and urinary tract infection. Multidermatomal herpes zoster, esophageal candidiasis, pneumocystis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with Olumiant.

Pregnancy and Lactation

Based on animal studies, Olumiant may cause teratogenic effects when administered during pregnancy. Women should not to breastfeed during treatment with Olumiant and for 4 days after the last dose.

Hepatic and Renal Impairment

  1. Olumiant is not recommended in patients with RA or AA and severe hepatic impairment or severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73m2).
  2. Olumiant should only be used in patients with COVID-19 and severe hepatic impairment if the potential benefit outweighs the potential risk.
  3. Olumiant is not recommended in patients with COVID-19 who are on dialysis, have end-stage renal disease, or with eGFR <15 mL/min/1.73m2.