Novartis: The US to allow clinical trials of hydroxychloroquine for the treatment of COVID-19

The head of the company said that he had the highest hopes for this drug.

ZURICH-Swiss pharmaceutical company Novartis has received permission from the US Food and Drug Administration (FDA) to conduct randomized trials of the antimalarial drug hydroxychloroquine for the treatment of COVID-19.

This was announced by the company itself on Monday.

Earlier this month, the FDA authorized the use of this untested generic drug, developed several decades ago, to treat coronavirus in emergency cases, but there is no scientific evidence of its effectiveness yet.

There are currently no approved medications for the treatment of COVID-19.

In the coming weeks, Novartis plans to recruit 440 patients for the third phase of clinical trials from more than a dozen localities in the United States. The results will be reported as soon as possible, the company said.

The use of a 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 untested drug to treat COVID-19 led to the FDA’s decision to do so, bypassing the usual formalities.

“We are aware of the importance of getting an answer to the scientific question about the benefits of hydroxychloroquine for patients with COVID-19,” said John Tsai, lead drug developer at Novartis. – We quickly organized to address this issue in a randomized, double-blind, placebo-controlled trial.”

Such companies as Novartis, Gilead Sciences and Roche are testing existing drugs developed to treat other diseases for signs that they can be repurposed to fight the coronavirus epidemic.

Gilead Sciences recently expanded the test of its drug receiver intended for the treatment of Ebola.

However, there are concerns that statements by Trump and others that hydroxychloroquine could “dramatically change the situation” with COVID-19 have pushed into the background information about the dangerous side effects of this drug, including vision loss and heart problems.

Novartis Chief Executive Vas Narasimhan also said that he has the highest hopes for this drug in the fight against the viral epidemic.

Hydroxychloroquine is the subject of several studies in the United States, including at the University of Washington and the University of Minnesota, as well as at the National Institutes of health.

Novartis’ subsidiary, Sandoz, which makes generic drugs, has pledged to donate 130 million doses of the drug. The pharmaceutical company Sanofi also intends to donate 100 million doses of hydroxychloroquine to 50 countries.

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