Eighteen months after endorsing Eli Lilly and Incyte’s Olumiant in combination with Gilead’s Veklury for hospitalized COVID-19 patents, the FDA has given a full blessing to Olumiant as a standalone treatment.
The United States regulator signed off on Olumiant’s use in hospitalized adults who require supplemental oxygen, ventilation, or extracorporeal membrane oxygenation (ECMO). Olumiant is the only immune system modulator and only JAK inhibitor sanctioned for use against the virus.
Originally endorsed in 2018 as a treatment for rheumatoid arthritis, Olumiant became one of the first drugs used to combat COVID when it was authorized for emergency use alongside Veklury in November of 2020.
Then, last July, the FDA authorized Olumiant’s use as a standalone for hospitalized COVID patients who needed oxygen. The drug is taken in tablet form, a daily 4 mg dose for up to 14 days.
Tuesday’s approval does not include pediatric patients ages 2 to 17. They remained covered under July’s EUA expansion.