FDA Announces Two Drugs Given ‘Compassionate Use’ Status in Treating COVID-19

Two drugs, chloroquine and remdesivir, are being designated for Expanded Access, or “compassionate use,” by the FDA to address the novel coronavirus (COVID-19) pandemic, according to FDA Commissioner Stephen Hahn, MD, and President Donald Trump.¹

Chloroquine and remdesivir are not FDA-approved for a COVID-19 indications, but Expanded Access allows patients with serious or life-threatening cases of the virus to have access to them as investigational medicinal products.²

Chloroquine, or hydroxychloroquine, is currently approved by the FDA for treatment of malaria, lupus, and rheumatoid arthritis, although not for COVID-19. A heme polymerase inhibitor, the drug is being tested for possible COVID-19 use to improve virologic clearance.³

Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity, according to its maker, Gilead Sciences, and it is not approved by the FDA nor any other countries for any use. However, remdesivir has demonstrated activity against MERS and SARS, indicating that it may have potential activity against COVID-19. The drug has been used in a small number of patients with COVID-19 in an experimental manner, according to Gilead.⁴

During a White House press conference on Thursday, Hahn said that although remdesivir is still in its investigational phase, the unprecedented pandemic warranted action. “Remdesivir is [still] going through the normal process. We do need to know about the safety and effectiveness,” he said.¹

According to Hahn, the FDA is providing regulatory flexibility and guidance, but is also continuing to ensure products are safe. He said the agency has been working with the CDC since January on combating the virus.¹

“An important part of that work is expanding therapeutic options for the coronavirus,” Hahn said.¹

Trump said these medications will be made available by prescription. Hahn declined to say when both drugs would become available for use in patients with COVID-19.¹

For up-to-date information on COVID-19 for pharmacy professionals, visit Pharmacy Times' coronavirus resource center.

REFERENCES

• Coronavirus Task Force. White House Press Conference. Presented: March 19, 2020. Accessed March 19, 2020.
• FDA. Expanded Access. FDA website. https://www.fda.gov/news-events/public-health-focus/expanded-access Updated May 6, 2019. Accessed March 19, 2020.
• Bulloch M. Potential Pipeline Medications May Help Patients with Novel Coronavirus. Pharmacy Times. https://www.pharmacytimes.com/news/potential-pipeline-medications-for-the-coronavirus Published March 11, 2020. Accessed March 19, 2020.
• Gilead Sciences. Gilead Sciences Update On the Company’s Ongoing Response to COVID-19. Gilead Sciences website. https://www.gilead.com/purpose/advancing-global-health/covid-19 Updated February 26, 2020. Accessed March 20, 2020.