Novartis announces plan to initiate clinical study of Jakavi® in severe COVID-19 patients and establish international compassionate use program
- New clinical trial to evaluate Jakavi® (ruxolitinib) in patients with COVID-19 associated cytokine storm
- Cytokine storm is a type of severe immune overreaction that can result from coronavirus infection and may contribute to respiratory compromise in patients with COVID-191-3.
- Pre-clinical and preliminary clinical evidence suggests Jakavi, a well-established JAK inhibitor, could reduce the number of patients requiring intensive care and mechanical ventilation2.
- Novartis to establish compassionate use program for COVID-19 patient access and undertake steps to ensure uninterrupted supply of Jakavi for currently licensed indications
In response to the coronavirus pandemic, Novartis is assessing whether certain Novartis’ existing medicines could be repurposed to treat patients with coronavirus infection. Novartis today announced plans to initiate a Phase III clinical trial in collaboration with Incyte to evaluate the use of Jakavi® (ruxolitinib) for treatment of a type of severe immune overreaction called cytokine storm that can lead to life-threatening respiratory complications in patients with COVID-191-3.
The decision is based on pre-clinical evidence and preliminary reports from independent studies, and is supported by extensive data on the safety and efficacy of Jakavi in conditions like acute graft versus host disease and myeloproliferative neoplasms. 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 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,” said John Tsai, Head Global Drug Development and Chief Medical Officer, Novartis. “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 also has 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.
Novartis commitment and response to COVID-19
Novartis is deeply dedicated to the global effort to combat COVID-19 and doing our part to support the stability of global healthcare systems. We announced a broad set of measures including the creation of a global fund of USD 20 million to support communities around the world impacted by the COVID-19 pandemic. Novartis also has committed 130 million doses of hydroxychloroquine to support pandemic response. In addition, Novartis joined two key cross-industry research initiatives, the COVID-19 Therapeutics Accelerator, coordinated by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard, as well as a COVID-19 directed partnership organized by the Innovative Medicines Initiative (IMI). Novartis is separately supporting COVID-19 related clinical investigations of several Novartis medicines. To support access, the Novartis generics and biosimilars division Sandoz became the first company to commit to keeping stable prices for a basket of essential medicines that may help in the treatment of COVID-19.
Novartis, a part of which are Lek d.d., Sandoz d.d. and Novartis Pharma Services donated to the Slovenian Red Cross and the Slovenian Association of Friends of Youth USD 500,000 from the Novartis’ Global Fund to support their efforts to mitigate the pandemic caused by the new Coronavirus. In addition, Novartis in Slovenia has so far provided more than 20 health centers, hospitals, nursing homes and local communities across Slovenia with personal protective equipment and more than 4,000 liters of disinfectant.
More information about the Novartis response to COVID-19 is available on Novartis.com/coronavirus. More information about measures, taken in Slovenia, is avaliable on https://www.lek.si/sl/o-nas/za-medije/covid-19/.
About Jakavi® (ruxolitinib)
Jakavi (ruxolitinib) is an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases. Jakavi is approved by the European Commission for the treatment of adult patients with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea and for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (MF) (also known as chronic idiopathic MF), post-polycythemia vera MF or post-essential thrombocythemia MF. Jakavi is approved in 101 countries for patients with MF, including EU countries, Switzerland, Canada, Japan and in more than 75 countries for patients with PV, including EU countries, Switzerland, Japan and Canada. The exact indication for Jakavi varies by country. Additional worldwide regulatory filings are underway in MF and PV.
- »NCI Dictionary of Cancer Terms: cytokine release syndrome.« National Cancer Institute, www.cancer.gov/publications/dictionaries/cancer-terms/def/cytokine-release-syndrome. Dostopano 28. marec 2020.
- Mehta, Puja, et al. »COVID-19: Consider Cytokine Storm Syndromes and Immunosuppression.« The Lancet, vol. 395, no. 10229, 28 Mar. 2020, pp. 1033–1034, doi: 10.1016/s0140-6736(20)30628-0.
- Shimabukuro-Vornhagen, Alexander, et al. »Cytokine Release Syndrome.« Journal for ImmunoTherapy of Cancer, vol. 6, no. 56, 15 June 2018, doi:10.1186/s40425-018-0343-9.
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This press release contains statements and conclusions based on projections of Lek’s future business operations. These estimates are derived from the best information currently available. In case these forecasts prove unreliable, the actual results could prove different from those projected.
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