Incyte, Novartis aim to make Jakafi available in severe COVID-19 after narrow trial miss

Jakafi
Jakafi missed its endpoint in a phase 3 trial in severe COVID-19. (Incyte)

Over the span of more than a year during the pandemic, pharma companies of all stripes have tested their existing medicines against COVID-19. Incyte is one of them.

Unfortunately, Incyte’s Jakafi fell just short in a phase 3 COVID trial. But now the company and its partner Novartis are determined to forge ahead, saying the data showed enough promise to make the JAK inhibitor a viable option for severely ill patients.

In the trial, dubbed Devent, Jakafi showed a mortality improvement that fell short of statistical significance, Incyte said. But in U.S. patients, who made up more than 90% of the study, Jakafi’s ability to help patients survive their illness did achieve statistical significance. The drug is approved to treat polycythemia vera, myelofibrosis and graft-versus-host disease.

Investigators tested Jakafi plus standard care against standard care alone in 211 patients on mechanical ventilation with COVID-associated acute respiratory distress syndrome. The primary endpoint measured was death from any cause through day 29.

In the U.S. trial population of 191 patients, the drug’s mortality benefit met statistical significance at both the 5 mg and 15 mg doses, Incyte said. Plus, a post-hoc analysis for the entire study population that pooled both doses together versus placebo met statistical significance.

More than half of patients in the study received Gilead’s antiviral Veklury, and 90% received corticosteroids, Incyte said.

RELATED: Novartis, Incyte will take Jakafi into 2nd trial for COVID-19 patients on ventilators 

With the results, Incyte is discussing an expanded access program with the FDA to make the drug available to patients at no cost. Under the program, if approved, patients with severe COVID-19 associated acute respiratory distress syndrome requiring ventilation could receive the drug. The company has plenty of drug supply for the effort, Incyte said.

There’s still a “significant unmet medical need” for severe COVID-19, Incyte CMO Steven Stein said in a statement. The company hopes the results “contribute to the advances being made across the scientific community to alleviate the burden this pandemic has placed on patients, as well as the healthcare system.” 

Novartis, which markets the drug outside of the U.S., plans to make the medicine available in other countries under a managed access program subject to local regulations, a spokesperson said. 

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Jakafi is one of many drugs the pharma industry has tested against COVID-19. Most haven’t panned out, but there are exceptions—such as Gilead’s Veklury, Eli Lilly’s Olumiant and Roche’s Actemra, which has posted mixed data. Meanwhile, newly developed monoclonal antibodies, including those from Eli Lilly and Regeneron, are now authorized to treat the disease.

In addition, COVID-19 vaccines have proved to be a bright point for the industry’s research efforts. Several are already launching in the U.S. and around the world, and more are in the pipeline.