Swiss pharmaceutical company Novartis has received approval from the U.S. Food and Drug Administration (FDA) to conduct randomized testing of the antimalarial agent hydroxychloroquine for treatment of COVID-19.
This was announced by the company itself on Monday.
Earlier this month, the FDA authorized the use of this unverified generic drug, developed decades ago, for the treatment of coronavirus in emergency cases, but there is no scientific evidence of its effectiveness.
There are currently no approved drugs to treat COVID-19.
In the coming weeks Novartis plans to recruit 440 patients for the third phase of clinical trials from more than a dozen communities in the U.S.. Their results will be announced as soon as possible, the company said.
The use of the drug, approved for the treatment of lupus and rheumatoid arthritis, has increased dramatically after it was supported by President Donald Trump. There are concerns that the administration’s support for an unverified drug to treat COVID-19 has led to the FDA’s decision to bypass routine formalities.
“We recognize the importance of getting an answer to the scientific question about the benefits of hydroxychloroquine for patients with COVID-19,” said John Cai, a leading drug developer at Novartis. – We quickly organized ourselves to address this issue in a randomized, double-blind, placebo-controlled study.
Companies such as Novartis, Gilead Sciences and Roche are testing existing drugs developed to treat other diseases for signs that they can be repurposed to combat the coronavirus epidemic.
Gilead Sciences has recently extended the testing of its Remdezivir, a drug designed to treat Ebola.
However, there are concerns that Trump’s and others’ claims that hydroxychloroquine may “make a difference” with COVID-19 have overshadowed information about its dangerous side effects, including loss of vision and heart problems.
Novartis Executive Director Vas Narasimkhan also said he has the highest hopes for this drug in the fight against the virus epidemic.
Hydroxychloroquine is also the subject of several studies in the US, including at the University of Washington and the University of Minnesota, as well as the National Institutes of Health.
A subsidiary of Novartis, Sandoz, which produces generics, has promised to donate 130 million doses of the drug. The pharmaceutical company Sanofi also intends to donate 100 million doses of hydroxychloroquine to 50 countries.