Swiss Novartis Group obtains US Food and Drug Administration (FDA) approval to conduct clinical trials for hydroxychloroquine malaria drugs to treat COVID-19.
The generic drug that has been on the market for several decades this month has obtained FDA approval for use against COVID-19, but it does not yet provide scientific evidence that it works. Currently, there are no officially approved drugs for the treatment of COVID-19.
Novartis plans to recruit 440 patients for a 3-stage (late-stage) clinical trial in more than 12 locations in the United States in the coming weeks. The results will be reports as soon as possible, the company said.
The use of the drug, which is also approved for lupus and rheumatoid arthritis, increased after it was promoted by President Donald Trump, but there were also concerns that support from the White House administration for using a drug not approved for COVID-19 shortened the process. FDA regulations.
Companies such as Novartis, Roche and Gilead Sciences are testing older drugs, developed to treat other diseases, for possible use in treating coronavirus outbreaks.
However, there are fears that the promotion of hydroxychloroquine by Trump and other officials as a drug that can “change the game” in the case of COVID-19 will leave dangerous side effects in the shadows, such as vision loss and heart problems.
Novartis general manager Vas Narasimhan said the drug was the month of his highest hopes for use in the coronavirus outbreak.
Several other hydroxychloroquine studies are currently in progress, including
The University of Washington and the University of Minnesota, as well as the National Institutes of Health.
Sandoz Division of Novartis Group has pledged to donate 130 million doses of hydroxychloroquine. Sanofi has announced that it will donate 100 million doses of hydroxychloroquine to 50 countries.