Novartis has unveiled plans to commence a clinical trial of Jakavi (ruxolitinib) in severe COVID-19 patients and establish an international compassionate use programme.
Novartis will work with Incyte to begin a phase III clinical study to assess the application of Jakavi to treat cytokine storm, a type of severe immune overreaction that may cause respiratory complications in patients with COVID-19.
The Swiss firm said that its decision is based on pre-clinical evidence and preliminary reports from independent studies, as well as supported by comprehensive data on the safety and efficacy of Jakavi in conditions such as acute graft versus host disease and myeloproliferative neoplasms.
The proposed study will evaluate Jakavi in combination with standard of care (SoC) therapy compared against SoC therapy alone in patients with severe COVID-19 pneumonia due to SARS-CoV-2 infection.
Novartis has also announced the creation of an international compassionate use programme for eligible patients, subject to local regulations. The ruxolitinib access requests are monitored by Incyte in the US.
Jakavi, an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases, secured approval from the European Commission (EC) to treat adult patients with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea.
It is also approved to treat disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (MF), post-polycythemia vera MF or post-essential thrombocythemia MF.
Jakavi secured approval in 101 countries for patients with MF, as well as in over 75 countries for patients with PV.
Novartis secured a licence for ruxolitinib from Incyte to develop and commercialise in selected indications outside the US.
In the US, Incyte commercialised ruxolitinib as Jakafi for patients with PV who have had an inadequate response to or are intolerant of hydroxyurea, for patients with intermediate or high-risk MF, and steroid-refractory acute GvHD in adult and pediatric patients 12 years and older.
Novartis global drug development head and chief medical officer John Tsai 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 enrol eligible patients, as well as put in place a process to provide access for patients unable to participate in the trial.”
In March this year, Novartis and a consortium of life sciences companies have collaborated with Bill & Melinda Gates Foundation (BMGF) to advance the development, manufacture and delivery of vaccines, diagnostics and treatments for COVID-19, the disease resulted due to the novel coronavirus SARS-CoV-2.