FDA approves hydroxychloroquine new drug application to address COVID-19 related shortage
The FDA has approved an abbreviated new drug application for hydroxychloroquine sulfate tablets to address ongoing shortages of the drug sparked by its still unproven potential as a COVID-19 treatment.
The application, submitted by Accord Healthcare, was approved on April 7. The approved indications are uncomplicated malaria due to Plasmodium falciparum, P. malariae, P. ovale, and P. vivax; chronic discoid lupus erythematosus and systemic lupus erythematosus in adults; and acute and chronic rheumatoid arthritis in adults.
“This is very good news for those with rheumatic conditions such as lupus,” Alfred H.J. Kim, MD, PhD, of the Washington University School of Medicine, in St. Louis, Missouri, told Healio Rheumatology. “The ANDA explicitly outlines the conditions known to respond to HCQ, such as SLE, RA, malaria, and excludes both the therapeutic and prophylactic use in COVID-19 due to circumstantial data. This will facilitate multiple suppliers to manufacture HCQ generically. We will help alleviate the current supply constraints, and we hope this happens quickly.”
Hydroxychloroquine and chloroquine are being tested in an international trial launched by WHO to find potential therapies for the disease. However, widely reported comments from President Donald Trump championing its use as a treatment for COVID-19, despite the current lack of clinical trial results, have triggered a surge in demand for the drugs. Rheumatologists have reported that many of their patients have experienced trouble accessing the medications to treat their RA or lupus.
On March 28, the FDA issued an Emergency Use Authorization, which allowed hydroxychloroquine and chloroquine products that were donated to the SNS to be distributed and used for adolescent and adult patients hospitalized with COVID-19 who cannot be part of a clinical trial.
According to HHS, 30 million doses of hydroxychloroquine sulfate have been donated to the Strategic National Stockpile by Sandoz, the genetics and biosimilars division of Novartis, and Bayer Pharmaceuticals donated 1 million doses of chloroquine phosphate to the national stockpile. The drugs have been provided for possible use in treating patients hospitalized with COVID-19, or for use in clinical trials, the department said.
Both hydroxychloroquine sulfate and chloroquine phosphate tablets have been listed on the FDA’s drug shortages website since March 31.
“The agency is working with manufacturers to assess their supplies and is actively evaluating market demand for patients dependent on hydroxychloroquine and chloroquine for treatment of malaria, lupus and rheumatoid arthritis,” said the FDA in a statement on its website. – by Jason Laday
Disclosures: Kim reports personal fees from Exagen Diagnostics and GlaxoSmithKline, as well as grants from the NIH and the Rheumatology Research Foundation.