New information released Tuesday by GlobalData showed that there are now more than 718 pipeline drugs associated with COVID-19. In addition, 70% of these products are in the discovery or preclinical stages.
“These drugs include combinations of novel agents and repurposed drugs, and new ones are added daily as new studies are announced or completed at a rapid rate,” said Johanna Swanson, product manager at GlobalData.
According to the most recent statistics, there are more than 2,000 clinical trials being conducted around the world, with 398 of them focused on chloroquine or hydroxychloroquine. A total of 22 of them are trials looking into remdesivir, an investigational drug that is still being examined by the U.S. Food and Drug Administration (FDA) for use in patients.
Gilead Sciences released new data on June 1 from its Phase III SIMPLE trial, examining remdesivir and how it can potentially help hospitalized COVID-19 patients with moderate pneumonia. The open-label study evaluated five-day and 10-day courses of remdesivir when used with standard care, versus standard care alone.
Statistics from the Phase III SIMPLE trial showed that patients in the five-day remdesivir treatment group were 65% more likely to show clinical improvement at Day 11, compared to their counterparts. The odds of improvement in clinical status with the 10-day treatment course of remdesivir versus standard care alone were also favorable. However, they did not show statistical significance.
“Our understanding of the spectrum of SARS-CoV-2 infection severity and presentations of COVID-19 continues to evolve,” said Francisco Marty, MD, an infectious diseases physician at Brigham and Women’s Hospital, and associate professor of medicine at Harvard Medical School. “These study results offer additional encouraging data for remdesivir, showing that if we can intervene earlier in the disease process with a 5-day treatment course, we can significantly improve clinical outcomes for these patients.”
On June 15, the FDA issued a new warning to healthcare providers pertaining to a new drug interaction related to remdesivir, which had received emergency use authorization for the treatment of hospitalized COVID-19 patients. The FDA revised its fact sheet for healthcare providers to reflect the potential interactions between remdesivir and chloroquine phosphate or hydroxychloroquine sulfate – the co-administration of remdesivir with these products may reduce the antiviral activity of the drug, according to the FDA.
The FDA is not aware of any instances of this reduced activity occurring in a clinical setting, but is continuing to evaluate the use of remdesivir and all data surrounding the drug.
“Over the course of this unprecedented pandemic, the FDA has issued emergency use authorizations for a variety of medical products after evaluating the available scientific evidence and carefully balancing any known or potential risks against the benefits of making these products available during the current public health emergency,” said Patrizia Cavazzoni, M.D., acting director of the FDA’s Center for Drug Evaluation and Research. “We understand that, as we learn more about these products, changes may be necessary based on new data – such as today’s updates for health care providers about a potential drug interaction and other important information about using remdesivir to treat COVID-19 patients. As we have done throughout the pandemic, the FDA continues to evaluate all of the emergency use authorizations issued and their related materials and will continue to make changes as appropriate based on emerging science and data.”
