Novartis will initiate a Phase III clinical trial in collaboration with Incyte to evaluate the drug Jakavi for the treatment of severe immune overreactions caused by the coronavirus.
The reaction – called cytokine storm — can lead to life-threatening respiratory complications in patients with COVID-19.
The proposed trial will assess Jakavi (ruxolitinib) in combination with standard of care (SoC) therapy in patients with severe COVID-19 pneumonia as a result of SARS-CoV-2 infection. The decision to initiate a trial is based on pre-clinical evidence and preliminary reports from independent studies along with extensive data on the efficacy of Jakavi in certain conditions.
“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 utilized beyond their approved indications,” John Tsai, head of global drug development and chief medical officer at Novartis, said. “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.”
Further, Novartis has set up an international compassionate use program for eligible patients, subject to local regulations. Also, the company is 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.
Jakavi (ruxolitinib) is an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases. The European Commission approved Jakavi for the treatment of adult patients with polycythemia vera (PV) who are intolerant of hydroxyurea.
Novartis licensed ruxolitinib from Incyte Corp. for development and commercialization in selected indications outside the United States. Ruxolitinib is marketed in the United States by Incyte Corp. as Jakafi for patients with PV.