Eli Lilly Gets FDA Approval For COVID Treatment, WHO Doubts Gilead's Remdesivir

Eli Lilly CEO David Ricks says the WHO's recommendation against remdesivir "throws some confusion out there" after getting FDA approval for a treatment that includes Gileads' key drug.

Eli Lilly & Co.  (LLY) - Get Report shares edged higher Friday after its rheumatoid arthritis treatment was granted emergency use approval by the Food & Drug Administration in combination with Gilead Sciences'  (GILD) - Get Report remdesivir. 

The decision to allow the use of baricitinib under the FDA's Emergency Use Authorization (EUA), however, followed a recommendation from the World Health Organization that advised against the use of remdesivir, saying a worldwide study, known as 'Solidarity', failed to show improvements in patient conditions. 

The results contradict a study of remdesivir published last month in the New England Journal of Medicine, which detailed patient recoveries that were five days faster, as well as consistent and meaningful improvements in outcomes compared those given placebos in a double-blind Phase 3 study.

Eli Lilly CEO David Ricks said the WHO decision "throws some confusion out there", while Gilead said it was "disappointed" that the guidelines would be issued at at time when coronavirus cases are rising in many countries around the world.

"Remdisivir is recognized as a standard of care for the treatment of hospitalized patients with COVID-19 in guidelines from numerous credible national organizations, including the US National Institutes of Health and Infectious Diseases Society of America, Japan, UK and Germany," Gilead said in a statement. 

"These recommendations are based on the robust evidence from multiple randomized, controlled studies published in peer-reviewed journals that demonstrate the clinical benefits of Veklury, such as significantly faster recovery, which can free up limited hospital resources," the statement added.

Eli Lilly shares were marked 0.11% lower in the opening minutes of trading Friday to change hands at $143.25 each. Gilead Sciences shares, meanwhile slipped 1.3% lower to $59.84 each. 

Olumiant, the brand name for baricitinib, was tested in combination with remdesivir, branded as Veklury, on hospitalized COVID-19 patients in a study arranged by the National Institute of Allergy and Infectious Diseases. The trial found the combined therapies resulted in a one-day reduction in recovery times.

Earlier Friday, the FDA received an EUA application from Pfizer Inc. PFE, which, along with its German partner BioNTech BNTX, has developed a coronavirus vaccine that reached a 95% efficacy rate following final clinical trials earlier this week. 

The treatment and vaccine developments come at a crucial time in the fight against the year-long pandemic, which has taken the lives of more than 1.3 million people around the world.

U.S. cases are rising at a record rate of 185,000 per day, according to data from Johns Hopkins University, and the Centers for Disease Control have warned that the U.S. death toll could reach 300,000 in early December.