Covid- 19 update: Notably, Dr. Reddy's, Fujifilm, and GRA had entered into a deal in July to sell Avigan globally excluding Japan, China, and Russia.
Covid- 19 update: Indian pharmaceutical giant Dr. Reddy’s Laboratories on Wednesday said that it had terminated its clinical study of Fujifilm Holdings’ COVID-19 drug Avigan in patients with moderate to severe symptoms in Kuwait. This has come after data from the Kuwait trial, conducted in partnership with United Arab Emirates-based medical alliance Global Response Aid FZCO (GRA), showed that the difference in time taken by Avigan and placebo to resolve a sustained absence of oxygen in the tissues was not significant enough to continue the trial.
Notably, Dr. Reddy’s, Fujifilm, and GRA had entered into a deal in July to sell Avigan globally excluding Japan, China, and Russia. Avigan was approved as an anti-flu drug in Japan in 2014, and Fujifilm has been seeking approval for the drug as a treatment for Covid-19 since October.
However, Dr. Reddy’s will continue a late-stage North American trial of Avigan in patients with mild to moderate Covid-19 symptoms. The hospitalized patient study, conducted in Kuwait, on moderate to severe patients was one of the studies in the overall clinical program for Avigan, spanning the spectrum of Asymptomatic to severe cases of Covid in both outpatient and in-patient settings, Dr. Reddy’s said in a statement.
Dr. Reddy’s, in partnership with Appili Therapuetics and Global Response Aid, will continue the Phase 3 pivotal study (PRESECO) being conducted in North America in an out-patient setting. The PRESECO study aims to determine the efficacy of Avigan as an early treatment for Covid-19 patients with mild-to-moderate symptoms, with the goal of alleviating symptoms and preventing disease progression before the infection requires hospitalizations or other intensive interventions. Additional observational studies to evaluate the efficacy of Avigan as part of early treatment in Covid-19 patients are also initiated, Dr. Reddy’s said in the statement.