Novartis donates 20,000 doses of hydroxychloroquine for COVID-19 PEP clinical trial

Novartis announced today that it is donating 20,000 doses of hydroxychloroquine to the University of Washington for a COVID-19 PEP clinical trial. Sandoz, the company’s generics and biosimilars division, is facilitating the donation.

A large post-exposure prophylaxis study is being conducted by the University of Washington International Clinical Research Center with funding from the Bill & Melinda Gates Foundation as part of the COVID-19 Therapeutics Accelerator. The donation is expected to provide approximately 2,000 patients with a 14-day post-exposure regimen.

“Sandoz, and the generics industry as a whole, play a vital role through support across all sectors of the healthcare system to do all we can to discover an effective and safe treatment regimen for COVID-19,” said Carol Lynch, President of Sandoz Inc. “As part of our efforts to establish clear and generally accepted treatment protocols, we are providing the required allocation to the University of Washington to support this crucial clinical trial.”

Earlier this month, Novartis announced its commitment to donate up to 130 million doses (200mg tablets) of generic hydroxychloroquine to support the global COVID-19 pandemic response. Hydroxychloroquine is currently under evaluation in several clinical trials for the treatment of COVID-19, including this one by the University of Washington.

The commitment came just weeks after Sandoz was the first company to commit to keeping stable prices for a basket of essential medicines that may help in the treatment of coronavirus cases, in an initial contribution to the global effort to combat COVID-19 and ensure the stability of global healthcare systems.

Hydroxychloroquine sulfate has long been used for the treatment of uncomplicated malaria, as well as for some autoimmune diseases including systemic lupus erythematosis and rheumatoid arthritis in adults.

Chloroquine (CQ) phosphate demonstrated effective repression of the SARS-CoV-2 infection in vitro1, and has been described as the apparent “drug of choice” among several potential candidates for large-scale use – pending appropriate clinical evidence — due to its availability, proven safety record, and relatively low cost2.

Recently, CQ was added to the list of trial drugs in the Guidelines for the Diagnosis and Treatment of COVID-19 (sixth edition) published by National Health Commission of the People’s Republic of China.

Via Sandoz