FDA Warns Against Compounding Remdesivir as COVID-19 Treatment

Gilead Sciences’ FDA-approved antiviral treatment for COVID-19, Veklury (remdesivir), should not be compounded, the FDA has warned.

The agency said it has recently learned that “various entities” are offering to sell the active pharmaceutical ingredient (API) in remdesivir to compounders and that the products could be “substandard or counterfeit.” And even if they are not, compounders might find it hard to produce a final product that is sufficiently soluble and stable and has the right pH, the agency said.

The API is “complex” and there is no U.S. Pharmacopeia (USP) monograph or other public quality standard for use in the FDA-approved product. Compounders may end up with “dosage forms or routes of administration that are different from the FDA-approved drug,” and a low-quality product could harm patients, the agency said.

The FDA approved remdesivir for treating hospitalized COVID-19 patients last October, making it the first approved COVID-19 treatment in the U.S. (DID, Oct. 23, 2020). But one month later, a World Health Organization (WHO) expert panel that reviewed multiple trials found no evidence for the drug’s effectiveness in treating COVID-19 — and the WHO advised that its use be limited until there is more evidence of efficacy (DID, Nov. 23, 2020).

International researchers are still hopeful that the antiviral will prove effective as a treatment for COVID-19 infections and multiple clinical trials of remdesivir, either alone or in combination with other potential COVID-19 treatments, are in progress or planned. — Martin Berman-Gorvine