Olumiant (Baricitinib) Description
Olumiant (Baricitinib) is a Janus kinase inhibitor, which blocks one or more of a specific family of enzymes, interfering with the pathway that leads to inflammation. Its active substance, baricitinib, blocks the action of enzymes called Janus kinases that play an important role in immune processes that lead to inflammation.
JAKs are intracellular enzymes that transmit signals arising from cytokine or growth factor-receptor interactions on the cellular membrane to influence cellular processes of hematopoiesis and immune cell function, says the U.S. FDA.
Olumiant is an immunosuppressant (a medicine that reduces the activity of the immune system). Olumiant is a once-daily, oral JAK inhibitor approved in the U.S. and more than 70 countries to treat adults with moderate to severe rheumatoid arthritis. Olumiant was first authorized in the EU in February 2017.
Olumiant was recently approved in the European Union and Japan to treat adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy. The U.S. FDA-approved labeling for Olumiant includes a Boxed Warning for Serious Infections, Malignancy, and Thrombosis.
NDC CODE: 0002-4182
Eli Lilly and Company is a global health care leader based in Indianapolis, IN, that unites caring with discovery to create medicines that make life better for people worldwide.
Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development, and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com.
Olumiant (Baricitinib) Indication
Olumiant is a U.S. FDA-approved to treat moderately to severely active rheumatoid arthritis. OLUMIANT® (baricitinib) 2-mg is indicated for treating adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.
On November 19, 2020, the FDA issued an emergency use authorization to use baricitinib, in combination with remdesivir (Veklury), for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation. However, baricitinib is not authorized or approved as a stand-alone treatment for COVID-19.
Olumiant (Baricitinib) Adverse Reactions
Most common adverse reactions include: upper respiratory tract infections (16.3%, 11.7%), nausea (2.7%, 1.6%), herpes simplex (0.8%, 0.7%) and herpes zoster (1.0%, 0.4%) for Olumiant 2 mg and placebo, respectively.
Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Thrombosis, including DVT and PE, has been observed at an increased incidence in Olumiant-treated patients compared to placebo. Also, arterial thrombosis events in the extremities have been reported in clinical studies with Olumiant.
Olumiant (Baricitinib) Delivery
Baricitinib (Olumiant) is a prescription oral tablet. The recommended dose for this EUA is baricitinib 4-mg once daily for 14 days or until hospital discharge.
OLUMIANT (baricitinib) 1 mg (NDC 0002-4732-30); OLUMIANT (baricitinib) 2 mg (NDC 0002-4182-30).
Olumiant (Baricitinib) News
May 10, 2021 - Eli Lilly informed Reuters it had signed licensing agreements with Cipla Ltd, Lupin Ltd, and Sun Pharma to expand the availability of baricitinib in India for treating COVID-19 patients. Baricitinib has been given restricted emergency use by India's Central Drugs Standard Control Organisation for use combined with remdesivir (Veklury) for the treatment of hospitalized COVID-19 adult patients requiring supplemental oxygen.
April 30, 2021 - Through new analyses of BREEZE-AD5 Phase 3 clinical trial data and an extended safety analysis across multiple trials, Eli Lilly and Company and Incyte's Olumiant® (baricitinib) 2-mg tablet taken once daily showed improvement in key measured treatment outcomes compared to placebo, and helped further characterize the long-term safety profile in adults with moderate- to severe atopic dermatitis.
April 29, 2021 - The European Medicines Agency announced it has started evaluating an application to extend Olumiant (baricitinib) use to include treatment of COVID-19 in hospitalized patients from 10 years of age who require supplemental oxygen.
April 20, 2021 - Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced results from a second Phase 3 trial (BRAVE-AA1) evaluating the efficacy and safety of once-daily baricitinib 2-mg and 4-mg in adults with severe alopecia areata (AA). The data are consistent with findings from the first Phase 3 clinical trial, BRAVE-AA2, top-lined earlier this year. In both investigational trials, a statistically significant proportion of patients treated with baricitinib achieved the primary endpoint of hair regrowth across the two dosing regimens at Week 36 compared to patients treated with placebo. AA is an autoimmune disease that currently has no therapies approved by the U.S. Food and Drug Administration.
April 8, 2021 - Eli Lilly and Company and Incyte announced results of COV-BARRIER, a Phase 3 study evaluating baricitinib 4 mg once daily plus standard of care (SoC) versus placebo plus SoC. The trial did not meet statistical significance on the primary endpoint, which was defined as a difference in the proportion of participants progressing to the first occurrence of non-invasive ventilation including high flow oxygen or invasive mechanical ventilation including extracorporeal membrane oxygenation (ECMO) or death by Day 28. Baricitinib-treated patients were 2.7 percent less likely than those receiving standard of care to progress to ventilation (non-invasive or mechanical) or death, a difference that was not statistically significant (odds ratio [OR]: 0.85; 95% CI 0.67, 1.08; p=0.1800).
March 3, 2021 - Eli Lilly and Company and Incyte announced top-line results from BRAVE-AA2, a Phase 3 study evaluating the efficacy and safety of once-daily baricitinib 2-mg and 4-mg in adults with severe alopecia areata (AA). Both doses of baricitinib met the primary efficacy endpoint at Week 36, demonstrating a statistically significant improvement in scalp hair regrowth than those randomized to placebo. AA is an autoimmune disease that causes patchy hair loss on the scalp, face, and sometimes on other body areas that can progress. Baricitinib has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) to treat AA. This classification aims to expedite the development and review of drugs intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over already available therapies on a clinically significant endpoint(s). There are currently no FDA-approved treatments for AA.
November 19, 2020 - Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19.
Olumiant (Baricitinib) Clinical Trials
Olumiant is active in many different clinical trials for various indications, COVID-19, Alopecia, and Rheumatoid Arthritis.