Novartis discontinues hydroxychloroquine clinical trial based on slow enrollment, remains committed to pandemic research efforts
viernes, 17 July 2020 - 8:00am
Study discontinued due to feasibility of recruitment; no safety issues have been reported or efficacy conclusions made
Novartis remains committed to ongoing research and development for COVID-19
Supply of hydroxychloroquine (HCQ) from Novartis will continue for clinical trials and upon government requests worldwide
Basel, June 19, 2020 — Novartis has made the decision to stop and discontinue its sponsored HCQ clinical trial for COVID-19 due to acute enrollment challenges that have made trial completion infeasible. The recruitment challenge facing our HCQ trial has made it unlikely that the clinical team will be able to collect meaningful data in a reasonable timeframe to determine the effectiveness of HCQ in treating patients with COVID-19. No safety issues have been reported, and there are no conclusions on efficacy from the study.
Novartis will continue to provide supply of HCQ for ongoing investigator-initiated trials (IITs) and upon government requests, as appropriate, where certain conditions are met and the medicine is used in accordance with a nationally endorsed treatment protocol. Researchers at Novartis continue to monitor ongoing guidance from health authorities on the further study of HCQ for COVID-19, as well as the decision by the US Food and Drug Administration to stop the emergency use authorization of HCQ for COVID-19 treatment. In addition, ongoing studies involving other Novartis treatments continue, as well as the newly announced support of a potential vaccine. Novartis also continues to collaborate to find answers for COVID-19 through various partnerships with multi-stakeholder external consortia.
Novartis wishes to thank all of the patients, their families, investigators and healthcare professionals who played a vital part in our HCQ clinical trial (CJWT629A12301, NCT04358081) for COVID-19.
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Sandoz, a division of Novartis, is a world leader in generic and biosimilar pharmaceuticals. Our purpose is to pioneer patient access by developing and commercializing innovative and affordable approaches to address unmet medical needs. Our broad portfolio of high-quality drugs, covering all major therapeutic areas, represented sales of $9.7 billion in 2019. Sandoz is headquartered in Holzkirchen, in the Greater Munich area of Germany.