Novartis discontinues HCQ trial over enrollment challenges
Swiss drugmaker Novartis has announced to discontinue Hydroxychloroquine (HCQ) clinical trial over acute enrollment challenges that have made completion of the trial infeasible, and not because any safety issues were reported or efficacy conclusions made.
The Basel-based company said that it will, however, continue the worldwide supply of hydroxychloroquine for clinical trials and upon government requests.
“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,” the company said in a statement late on Friday.
“No safety issues have been reported, and there are no conclusions on efficacy from the study,” it added.
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 FDA to stop the emergency use authorization of HCQ for Covid-19 treatment,” said the company.
Novartis has donated up to 130 million doses of hydroxychloroquine, including millions in the US.
The World Health Organization (WHO) last week halted the testing of HCQ as a treatment for Covid-19 after new data showed no benefit.