Novartis Signs an Agreement with the US FDA to Evaluate Hydroxychloroquine in Patients with COVID-19
Shots:
- Novartis to initiate the P-III clinical study to assess hydroxychloroquine vs hydroxychloroquine + azithromycin vs PBO in 440 patients with COVID-19 at more than a dozen sites in the US. The drug will be supplied by Sandoz while Novartis intends to initiate the enrollment for the study within the next few weeks
- Novartis will make its hydroxychloroquine IP available to support broad access- if the therapy is approved for COVID-19. The clinical study complements Novartis’s donation up to 130M doses of hydroxychloroquine globally amid COVID-19 pandemic
- Novartis has formed a clinical investigation team to provide rapid access for approved clinical requests and support of the clinical evaluation of its therapies to be repurposed and addressing the needs of patients with COVID-19. Additionally- Novartis plans to sponsor or co-sponsor clinical studies to evaluate ruxolitinib and canakinumab for hospitalized patients with COVID-19
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