Current Edition

FDA converts emergency nod for Lilly’s Olumiant to a full approval for hospitalized COVID patients

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.

Nearly one million people in 15 countries have been treated with Olumiant since the outset of the pandemic, Eli Lilly said.

During that time, sales of the drug have increased steadily—from $427 million in 2019 to $639 million in 2020 and $1.115 billion last year. Last month, Lilly reported first quarter sales of Olumiant at $256 million, an increase of 32% from the first quarter of 2021. The drug has been used much more outside of the U.S. In 2021, for example, 29% of its sales were domestic.

The approval was based on two trials—one where Olumiant was used in conjunction with Veklury and the other where it was used as a standalone. Both studies showed the ability of the drug to reduce the risk of death and the length of hospitalization.

Gilead won a full approval for Veklury in October of 2020, following its authorization on an emergency basis. In January of this year, the FDA sanctioned the antiviral for at-risk patients with mild-to-moderate COVID. Its sales reached $5.6 billion last year.

Early in the pandemic, Lilly also gained approval for its antibody treatment bamlanivimab—first as a standalone and later as a combo therapy with etesevimab. But officials later sidelined the drugs after they were shown to be ineffective against the omicron variant.

More recently, the FDA endorsed Lilly’s newer antibody, bebtelovimab, which has been shown to be effective against omicron.