Novartis, Incyte set to roll JAK inhibitor Jakafi into COVID-19 clinical trial

Drugmakers across the board are rolling already approved drugs into late-stage clinical trials in an effort to find a speedy therapy for COVID-19. Now, two more are joining the party, with Swiss drugmaker Novartis and partner Incyte set to test their blockbuster JAK inhibitor.

Novartis and Incyte will initiate a phase 3 clinical trial for Jakafi––marketed as Jakavi abroad––to test it as a treatment for cytokine storm, an immune overreaction that causes respiratory complications in severe COVID-19 patients, the Swiss drugmaker said in a release.

The proposed blind, double-arm study will evaluate a combination of Jakafi alongside standard-of-care therapy to treat COVID-19 patients with pneumonia, the partners said.

Jakafi's potential star turn follows "pre-clinical evidence and preliminary reports from independent studies" showing possible efficacy against COVID-19, Novartis said in a release, as well as "extensive data on (Jakafi's) safety and efficacy" treating FDA-approved indications in acute graft-versus-host disease and myeloproliferative neoplasms.

“The potential that Jakavi could lead to faster recovery times for COVID-19 patients with fewer requiring intensive care and mechanical ventilation is encouraging and absolutely merits further investigation," said John Tsai, Novartis' chief medical officer and head of global drug development. "We now are moving rapidly to finalize the study plan and then to enroll eligible patients, as well as put in place a process to provide access for patients unable to participate in the trial.”

Novartis and Incyte are immediately rolling out a compassionate use program for Jakafi pending local regulations and "are taking steps" to handle an expected increase in demand that could affect patients already taking the prescribed med.

Jakafi, which the FDA initially approved to treat myelofibrosis in 2011, is also approved to treat polycythemia vera and chronic graft-versus-host disease. The drug raked in $1.1 billion in sales in 2019.

RELATED: The White House is pushing FDA to clear Fujifilm's Avigan for COVID-19. Should the agency obey?

Novartis and Incyte's campaign is only pharma's most recent push to repurpose already approved drugs to treat COVID-19.

Another of those meds, Fujifilm's flu antiviral Avigan, could soon get the FDA's backing for emergency use after President Donald Trump's explicit support.

The Trump administration on Thursday asked the FDA to authorize Avigan's emergency use, Politico reported, citing three officials familiar with the discussions and internal documents. Trump has previously talked up other drugs as promising against the novel coronavirus, including malaria meds chloroquine and hydroxychloroquine, which the FDA just cleared for emergency use without solid clinical evidence of its effect on COVID-19.

In China, where Avigan only won its first approval for flu during the early days of the pandemic, an official at the country’s Ministry of Science and Technology has labeled it as “clearly effective” in treating COVID-19, adding that the agency has recommended it to health authorities for consideration in its treatment guidelines.

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Among pharma's ever-expanding list of possible COVID-19 therapies, drugmakers have so far floated a range of possibilities with mixed clinical results.

Alongside HIV-fighters and other antivirals, drugs from the IL-6 inhibitor class––including Sanofi and Regeneron's Kevzara and Roche's Actemra––have piqued researchers' interest and prompted late-stage clinical trials of their own.

On Monday, Sanofi and Regeneron said they had dosed the first patient in their ex-U.S. arm of a global phase 2/3 clinical program evaluating Kevzara as a treatment for severe COVID-19. They will eventually enroll around 300 patients and study intravenous Kevzara as an add-on to supportive care through an "adaptive design," Regeneron said.

Two weeks ago, Sanofi and Regeneron heralded the U.S. arm of the program, saying the trial would test Kevzara as an add-on to supportive care in around 400 patients across 16 states.