Novartis, a Swiss multinational pharmaceutical company, has made an agreement with U.S. regulators to conduct randomized trials of generic hydroxychloroquine for the treatment of COVID-19, the disease caused by the novel coronavirus, aka SARS-CoV-2.
The Swiss drug company said on Monday that it would hold clinical trials on 440 patients who are hospitalized due to COVID-19.
Sold under the brand name Plaquenil, hydroxychloroquine is the oldest drug that has been used to treat and prevent uncomplicated malaria.
In addition, hydroxychloroquine is commonly prescribed to people who have autoimmune diseases such as lupus and rheumatoid arthritis.
The U.S. Food and Drug Administration (FDA) approved hydroxychloroquine for the treatment and prevention of malaria in 1955.
The drug has now received emergency approval for the treatment of COVID-19 because some studies have found the drug to be effective in treating the infection and helping patients to recover quickly.
However, there is no scientific evidence that it helps patients who are afflicted by the virus. Some experts, including NIAID head Dr. Anthony Fauci, said there is no strong evidence to prove that hydroxychloroquine is the standard treatment for COVID-19.
Dr. John Tsai, Head of Global Drug Development and Chief Medical Officer for Novartis, said, “We recognize the importance of answering the scientific question of whether hydroxychloroquine will be beneficial for patients with COVID-19 disease.”
President Donald Trump has been promoting hydroxychloroquine and even called it a game-changer when it comes to treating the new coronavirus. Referring to some clinical studies, he said the drug has shown “very encouraging” results in treeing COVID-19.
However, some experts expressed concerns over the Trump administration’s advocacy for an unproven drug for treating COVID-19. They said it is important to conduct more studies before concluding that hydroxychloroquine is effective at treating COVID-19.
Another malaria drug called chloroquine, which is structurally similar to hydroxychloroquine, has also been found effective in some trials. However, once again, there is no strong evidence yet.
