The U.S. Food and Drug Administration on Wednesday approved the use of chloroquine phosphate and hydroxychloroquine for emergency treatment of COVID-19 patients, despite a lack of clinical data on their efficacy.
According to financial daily Globes, the FDA is recommending controlled clinical trials to test the drugs’ effectiveness in treating COVID-19, the disease caused by the SARS-CoV-2 virus, but is allowing doctors to give them to patients in cases in which they cannot participate in such a trial.
Israeli pharmaceuticals giant Teva, one of the companies manufacturing hydroxychloroquine, announced last month that it would donate 10 million tablets to U.S. hospitals to treat coronavirus patients. Teva’s hydroxychloroquine has been previously approved for treating malaria, lupus and rheumatoid arthritis patients.
The hydroxychloroquine sulfate market in the United States is dominated by generic manufacturers, and in 2019 it amounted to $230 million. Teva’s market share is 9.2 percent, putting it in fourth place in this market, after Prasco (30.5 percent), Sandoz (28.2 percent) and Zydos Cadila (14 percent), the report said.
Also on Wednesday, Israel’s Magen David Adom national emergency service said it will begin treating coronavirus patients with a new “passive vaccine” created from plasma donated by patients who have recovered from the disease.
Magen David Adom deputy director of blood services professor Eilat Shinar explained that it is believed that those who have recovered from COVID-19 have developed special antivirus proteins or antibodies that can help sick patients fight off the disease.