ZURICH - Novartis has reached an agreement with U.S. regulators to hold a randomized trial of generic malaria drug hydroxychloroquine against COVID-19 disease in 440 hospitalized patients, the Swiss drugmaker said on Monday.
The decades-old medicine has received U.S. Food and Drug Administration (FDA) emergency use authorization for coronavirus disease, but so far there is no scientific proof it helps those afflicted.
"We recognize the importance of answering the scientific question of whether hydroxychloroquine will be beneficial for patients with COVID-19 disease,” said John Tsai, Novartis's top drug developer.
The drug, also used to treat lupus and rheumatoid arthritis, has been promoted by President Donald Trump, with some worried the administration's advocacy for an unproven medicine for COVID-19 has short-circuited the oversight process. (Reporting by John Miller, editing by John Revill)