EMA to Quickly Review Eli Lilly, Incyte Arthritis Drug for COVID-19 Use

By Reuters Staff

April 30, 2021

ZURICH (Reuters) - The European Medicines Agency will conduct an accelerated review of Eli Lilly and Co's rheumatoid arthritis drug Olumiant for hospitalized COVID-19 patients getting oxygen, the agency said on Thursday, as the search for treatment options continues.

Olumiant, on which Lilly partners with U.S. drugmaker Incyte Corp, is the latest arthritis medicine to be repurposed in efforts to combat COVID-19, with other prominent examples Actemra from Roche Holding AG and Kevzara from Sanofi SA.

While Actemra and Kevzara are large-molecule monoclonal antibodies, Olumiant is a so-called Janus kinase (JAK) inhibitor small-molecule drug that works by blocking action of enzymes that play a role in immune system processes that lead to inflammation.

The EMA is quickly reviewing data from Eli Lilly of two randomized trials of hospitalized patients. Olumiant, also called baricitinib, was given emergency use authorization in the United States in November 2020 to be deployed in combination with Gilead Sciences Inc's remdesivir, for COVID-19 patients.

"EMA will communicate on the outcome of its evaluation, which is expected to reach an opinion by July unless supplementary information is needed," the agency said in a statement.

While Olumiant, whose anti-autoimmune action has also made it a candidate to treat certain types of hair loss, has shown promise against severe COVID-19, not all JAK inhibitors have succeeded. Novartis AG's Jakavi, also called ruxolitinib and used to treat some forms of blood cancer, showed no significant benefit for COVID patients.

Repurposing drugs for COVID-19 can be lucrative, as Roche has reaped hundreds of millions in additional sales for Actemra since the pandemic began after trials that have offered mixed results. Olumiant sales rose 39% in the first quarter to about $194 million.