Eli Lilly and Company and Wilmington-based Incyte announced that the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the distribution and emergency use of baricitinib.
The drug is used in combination with remdesivir in hospitalized adult and pediatric patients with serious cases of Covid-19.Such cases require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
The FDA grants emergency use authorization to provide availability of a medicine that may help diagnose, treat, or prevent a life-threatening disease when no adequate and approved alternatives are available.
The authorization is temporary and does not replace the formal review and approval process. This is the first combination regimen authorized by FDA. An evaluation of baricitinib’s efficacy and safety as a treatment for Covid-19 is ongoing in clinical trials.
The EUA is based on data from the Adaptive Covid-19 Treatment Trial (ACTT-2), a study to evaluate the efficacy and safety of baricitinib in combination with remdesivir versus placebo with remdesivir in hospitalized patients with or without oxygen requirements conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
Patients treated with baricitinib combined with remdesivir had a significant reduction in median time to recovery from 8 to 7 days compared to remdesivir alone.
- Patients treated with baricitinib combined with remdesivir were more likely to have a better clinical status at Day 15 compared to patients treated with remdesivir.
- The proportion of patients who progressed to ventilation or died by Day 29 was lower in baricitinib combined with remdesivir (23 percent) compared to remdesivir (28 percent).
- The proportion of patients who died by Day 29 was 4.7 percent for baricitinib combined with remdesivir vs. 7.1 percent for remdesivir, a relative reduction of 35 percent.
- Adverse events and serious adverse events were reported in 41 percent and 15 percent of patients treated with baricitinib in combination with remdesivir, respectively, vs. 48 percent and 20 percent in patients treated with remdesivir.
Andre Kalil, M.D., professor at the University of Nebraska Medical Center and a principal investigator of the ACTT studies, stated: “Few treatment options have received an EUA to treat COVID-19, so the authorization of baricitinib is an important step that will give healthcare providers another clinical tool to help patients with advanced disease.”
Baricitinib, an oral JAK inhibitor discovered by Incyte and licensed to Lilly, is approved and commercially available as Olumiant in the U.S. and more than 70 countries as a treatment for adults with moderate to severe rheumatoid arthritis and was recently approved in the European Union for the treatment of adult patients with moderate to severe atopic dermatitis.
The Food and Drug Administration placed restrictions on dosages of the drug, reducing its potential to be a blockbuster drug.
“As a company, we have worked quickly and collaboratively to determine the potential utility of our medicines as treatments for Covid-19 and its related complications,” said HervéHoppenot, IncyteCEO. “We are pleased that the FDA has authorized the use of baricitinib in combination with remdesivir for COVID-19, and look forward to the opportunity to make more therapies available to patients around the world affected by the global pandemic.”
Lilly is working with hospitals, healthcare professionals and governments to facilitate patient access to baricitinib and continues to explore the medicine’s potential use in Covid-19 with other regulatory agencies outside the U.S.
Concerning supply, Lilly remains confident in meeting patients’ needs under the EUA in the U.S. and for existing approved indications around the world.
The list priceof the drug is $2,265 for a 30-day supply of 2 mg tablets.