Novartis plans to submit its investigational COVID-19 antiviral treatment to the FDA for emergency use authorization before receiving results from a large clinical trial, CEO Vas Narasimhan, MD, told Bloomberg Law.
Dr. Narasimhan said the company is hoping to file for emergency use authorization within the next month.
On Jan. 10, Novartis released data showing the drug, ensovibep, reduced the risk of hospitalization, emergency room visits or death by 78 percent compared to a placebo group. The drug also reduced the viral load in patients' bodies over eight days, which was the study's main endpoint.
Based on positive results from the phase 2 trial, which involved 407 adults, Novartis said it is exercising an option to license ensovibep from Molecular Partners, a Swiss biopharmaceutical company.
A larger clinical trial to confirm this data is expected to wrap up by the second half of 2022, Dr. Narasimhan told Bloomberg Law.