The FDA revoked its emergency use authorization (EUA) for generic medicines chloroquine and hydroxychloroquine for COVID-19, saying it no longer had recognized health benefits.
Hydroxychloroquine is currently approved for treating malaria, lupus and rheumatoid arthritis. Notably, the safety and efficacy of hydroxychloroquine is being evaluated in large clinical studies by companies like Novartis (NVS - Free Report) for the treatment of COVID-19.
The FDA had allowed the use of hydroxychloroquine for EUA for COVID-19 in March as according to some preliminary results from independent pilot studies, hydroxychloroquine was reported to have a potential anti-viral effect on the virus that causes COVID-19. These generic medicines are not yet approved to treat COVID-19 but the EUA allowed hospitals to treat COVID-19 patients with these medicines. In April, however, the FDA had cautioned against the use of the medicines outside of the hospital setting or a clinical trial due to risk of heart rhythm complications.
However, now the FDA stated that the medicines are unlikely to prove effective in treating COVID-19 and may not be approved based on data from the studies. The known benefits of chloroquine and hydroxychloroquine no longer outweigh the risks for authorized use, per the FDA. The medicines thus no longer meet the statutory criteria for issuance of EUA. According to the FDA, use of chloroquine and hydroxychloroquine has been linked to serious cardiac events and other potential serious side effects. The FDA went on to say that data from clinical studies have shown that chloroquine and hydroxychloroquine are not effective in inhibiting the SARS-CoV-2 virus that causes COVID-19. Recent data from a large clinical study showed that hydroxychloroquine did not reduce mortality in hospitalized COVID-19 patients
We remind investors that toward May end, Sanofi (SNY - Free Report) temporarily stopped recruitment of new patients in its two clinical studies evaluating hydroxychloroquine as a potential treatment for COVID-19 due to concerns about safety. The move came alongside World Health Organization’s (WHO) decision to temporarily pause the hydroxychloroquine arm of their international clinical study —SOLIDARITY—because of concerns about the safety of the drug. Hydroxychloroquine is one of the drugs being studied in the SOLIDARITY study. However, WHO resumed the hydroxychloroquine arm of the study this month on the basis of the available mortality data.
Hydroxychloroquine came into limelight following its promotion by President Donald Trump as a potential treatment for COVID-19. He called it a ‘game changer’ and claimed to have used it himself. Demand for the drug soared thereafter.
Companies like Mylan (MYL - Free Report) ramped up manufacturing of the generic drug to meet the rising demand. Teva (TEVA - Free Report) and Sanofi donated millions of doses of hydroxychloroquine through wholesalers to hospitals across the United States.
Another drug that has been granted EUA for COVID-19 treatment is Gilead’s (GILD - Free Report) investigational antiviral remdesivir. Gilead is conducting phase III studies on remdesivir for COVID-19 treatment.
Gilead has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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