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Novartis, in alliance with Incyte, has announced plans to assess Jakavi (ruxolitinib) in a Phase III clinical trial to treat cytokine storm in patients with severe Covid-19 pneumonia.
Cytokine storm is a severe immune overreaction to the infection and leads to respiratory complications.
Jakavi is an oral, JAK 1 and JAK 2 tyrosine kinase inhibitor. It is approved in Europe to treat adults with polycythemia vera (PV) and symptoms caused by primary myelofibrosis (MF), post-polycythemia vera MF, or post-essential thrombocythemia MF.
Novartis licensed the drug from Incyte to develop and commercialise in certain indications outside the US. Incyte markets the drug in the US as Jakafi to treat PV, intermediate or high-risk MF, and acute GvHD in some patients.
The planned trial for Covid-19 will compare Jakavi and standard of care (SoC) therapy combination to SoC alone.
According to Novartis, the decision to assess the drug to treat coronavirus is based on pre-clinical evidence and preliminary data from independent studies. It is also supported by the safety and efficacy of the drug in other indications.
Novartis chief medical officer John Tsai said: “Novartis is taking a number of steps to address the urgent needs arising from the Covid-19 pandemic, including the evaluation of our existing therapies to assess if any can be utilised beyond their approved indications.
“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 finalise the study plan and then to enrol eligible patients, as well as put in place a process to provide access for patients unable to participate in the trial.”
Novartis has also launched an international compassionate use programme for eligible patients.