Swiss Pharm Co Wins FDA Approval To Start Hydroxychloroquine Clinical Trials In U.S.
Swiss pharmaceutical company Novartis has won approval from the U.S. Food and Drug Administration to begin a clinical trial on the efficacy of hydroxychloroquine in treating hospitalized COVID-19 patients.
The trial will begin immediately in more than a dozen sites across the U.S. and will include about 440 patients.
“We recognize the importance of answering the scientific question of whether hydroxychloroquine will be beneficial for patients with COVID-19 disease,” John Tsai, head of global drug development and chief medical officer at the company, said in a statement.
The new approval to move forward with clinical tests follows an earlier authorization from the FDA to allow emergency use of the drug, more widely used as a treatment for malaria.
President Trump has repeatedly touted hydroxychloroquine as a possible “game-changer” in the battle against SARS-CoV-2, the virus that causes COVID-19.
“HYDROXYCHLOROQUINE & AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine,” Trump wrote on Twitter earlier this month. “The FDA has moved mountains – Thank You!”
A recent international poll of more than 6,000 doctors found that hydroxychloroquine has been deemed the most highly rated treatment for the novel coronavirus.
The survey, conducted by Sermo, a global health care polling company, asked 6,227 physicians in 30 countries to find out what is the most effective against SARS-CoV-2. The poll found that 37% of those treating patients suffering from the coronavirus that causes COVID-19 rated hydroxychloroquine as the “most effective therapy” out of a list of 15 choices.
Azithromycin, known by the brand name Zithromax or Z-Pak, came in as the second-most effective therapy at 32%, followed by “nothing.”
Hydroxychloroquine, which is sold under the brand name Plaquenil, was prescribed mainly in the United States for the most severe cases. “Outside the U.S., hydroxychloroquine was equally used for diagnosed patients with mild to severe symptoms whereas in the U.S. it was most commonly used for high risk diagnosed patients,” the survey found.
Moreover, a recent French study found that the drug combo can be effective in counteracting the coronavirus COVID-19.
“Despite its small sample size, our survey shows that hydroxychloroquine treatment is significantly associated with viral load reduction/disappearance in COVID-19 patients and its effect is reinforced by azithromycin,” the study found.
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