Pharmaceutical giant Novartis has reached an agreement with US regulators to hold a randomised trial of generic malaria drug hydroxychloroquine against coronavirus in 440 hospitalised patients, the Swiss drugmaker said on Monday.
The decades-old medicine has received US Food and Drug Administration (FDA) emergency use authorisation 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.
Trump has strongly touted hydroxychloroquine as a coronavirus treatment although many scientists are urging caution until larger trials show whether it is safe and effective.
Hydroxychloroquine and another drug, chloroquine, have been used for decades against malaria but they have potentially serious side effects, especially in high doses or administered with other medications.
The European Medicine Agency has warned that the two drugs should not be used to treat COVID-19 cases, except for clinical trials or in the event of a "national emergency".
Reuters
