FDA Looks to Speed Access to Potential COVID-19 Treatments

Regulatory NewsRegulatory News
| 19 March 2020 | By Zachary Brennan 

With the potential for a coronavirus vaccine likely more than a year away, the US Food and Drug Administration (FDA) is doing what it can to speed access to potential COVID-19 treatments, President Donald Trump said in a press conference alongside FDA Commissioner Stephen Hahn on Thursday.

Specifically, Trump discussed one treatment that already has FDA approval, chloroquine, first approved as a malaria treatment more than 50 years ago, as well as another potential treatment, Gilead’s experimental antiviral remdesivir, which is in clinical trials in the US and China and which has been used in about 250 patients in the US on a compassionate use basis, according to FDA.

Trump at first said during the press conference that chloroquine has been approved by FDA as a COVID-19 treatment, but then FDA later clarified that the drug has not been approved for that indication. And although Trump praised the Right-to-Try law, Hahn noted that, unlike trials using Right-to-Try, compassionate use allows FDA to immediately collect information on experimental treatments and then make the right decisions about the safety and efficacy of those treatments.

Bayer, a manufacturer of chloroquine, said Thursday that it’s looking to obtain an Emergency Use Authorization for the drug in the US as a COVID-19 treatment. The company also said it’s donating three million tablets of the drug to the US government. Mylan on Thursday also said it has restarted production of hydroxychloroquine sulfate tablets at its West Virginia manufacturing facility to meet the potential for increased demand.

Rising Pharmaceuticals, another manufacturer of chloroquine in the US, said earlier this month that chloroquine phosphate 500 mg tablets are on back order and the company estimates a release date of mid-March, according to the American Society of Health-System Pharmacists.

Meanwhile, Hahn suggested that large clinical trials may be needed for testing chloroquine in patients with COVID-19 to understand if FDA can expand the use of that drug. FDA said in a statement that trials are underway to determine the efficacy in using chloroquine to treat COVID-19.

The University of Minnesota recently launched a trial for chloroquine for 1,500 patients. “Chloroquine or Hydroxychloroquine may have antiviral effects against SARS-COV2 which may prevent COVID19 disease or early preemptive therapy may ameliorate disease severity. This trial will use a modification of standard malaria dosing of hydroxychloroquine to provide post-exposure prophylaxis/preemptive therapy,” the ClinicalTrials.gov listing for the study says.

Hahn also mentioned that FDA is working on another treatment called convalescent plasma, which can be collected from people who have recovered from COVID-19. He said FDA has provided assistance on these types of treatments to other countries during this pandemic, and he explained how if the blood is pathogen-free, it could potentially help those with COVID-19. NIH said yesterday that it's looking for volunteers fully recovered from a COVID-19 infection to donate blood.


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