Novartis, Incyte test using Jakavi for respiratory problems in COVID-19 patients

Novartis said on Thursday it aims to start a Phase III clinical trial in collaboration with Incyte to evaluate the use of Jakavi (ruxolitinib) for the treatment of a type of severe immune overreaction called cytokine storm that can lead to life-threatening respiratory complications in patients with COVID-19.

Novartis and Incyte have based the decision on pre-clinical evidence and preliminary reports from independent studies. The proposed trial will assess Jakavi in combination with standard of care (SoC) therapy, compared to SoC therapy alone, in patients with severe COVID-19 pneumonia as a result of SARS-CoV-2 infection, Novartis said.

Novartis is also checking its existing therapies to assess if any can be used beyond their approved indications, in response to COVID-19 pandemic said John Tsai, Head Global Drug Development and Chief Medical Officer, Novartis.

He said that 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. “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.”

Given the rapid spread of the pandemic, and as plans for the study are finalized, Novartis said it has also set up an international compassionate use program for eligible patients, subject to local regulations. In addition, we are taking steps to manage the anticipated increase in COVID-19 related requests for Jakavi without interrupting access for patients taking the drug for its licensed indications. In the US, ruxolitinib access requests are coordinated by Incyte.