By Justin Wise – The Hill, 04/20/20 07:27 AM EDT
The U.S. Food and Drug Administration (FDA) and Novartis have reached an agreement to allow the Swiss pharmaceutical company to proceed with a clinical trial of hydroxychloroquine for patients with COVID-19, the disease caused by the novel Coronavirus.
Novartis announced on Monday that it will begin enrollment for phase III of the clinical trial within the next few weeks and that the study will be conducted in more than a dozen U.S. labs. The trial is set to evaluate the anti-malaria drug, which President Trump has repeatedly touted as a potential “game changer” in the fight against COVID-19. Health officials have insisted, however, that not enough is known about the drug to determine its efficacy.
The FDA last month issued an emergency-use authorization for hydroxychloroquine to be distributed and prescribed by doctors to COVID-19 patients when a clinical trial is not available.
The Novartis clinical trial will study the anti-malaria drug’s effects on approximately 440 patients, the company said, adding that the drug supply would be provided by Sandoz, its generics and biosimilars division.
“We recognize the importance of answering the scientific question of whether hydroxychloroquine will be beneficial for patients with COVID-19 disease,” John Tsai, head of global drug development and chief medical officer at Novartis, said. “We mobilized quickly to address this question in a randomized, double-blind, placebo-controlled study.”
Trump has repeatedly promoted hydroxychloroquine’s in recent weeks, even as health officials on the White House coronavirus task force stress that there is no scientific evidence the drug is effective in treating COVID-19. There is no cure for the virus, which has infected more than 2 million people worldwide.
The announcement from Novartis follows the company’s move to pledge 130 million tablets of hydroxychloroquine to supply global clinical research efforts focused on the drug. The Health and Human Services Department announced in March that it received 30 million doses.