Novartis has announced plans to begin clinical trials by phase III, which will help assess the effectiveness of the drug rukolaine for the treatment of severe forms of excessive reactions of the immune system known as cytokine storm. For patients with COVID-19 this condition can lead to life-threatening complications of the respiratory system. Research will be conducted in collaboration with pharmaceutical Incyte Corporation.
Novartis took a decision to review the operation of Roksolana for a new drug indication based on preclinical and preliminary clinical data as well as on verified information about the safety and efficacy of the drug in case of acute “graft versus host” and myeloproliferative malignancy in a patient. The study will assess the effectiveness of Roksolana in combination with standard therapy compared to standard therapy alone in patients with severe pneumonia COVID-19.
Roksolani is an oral inhibitor of the tyrosine kinases JAK1 and JAK2. The drug is approved by the European Commission for the treatment of adult patients with polycythemia Vera (SP) resistant to hydroxyurea, or in the case of intolerance, as well as for treatment due to disease splenomegaly or symptoms in adult patients with primary myelofibrosis (MF), MF after polycythemia Vera or essential thrombocythemia. For the treatment of MF rukolaine approved in 101 countries, and for the treatment of polycythemia Vera – in more than 75 countries, including Russia. Specific indications for the drug rukolaine in different countries may vary. Regulatory bodies worldwide continue to be new applications of MF and IE.