Gilead seeks ‘full-time’ approval for antiviral drug remdesivir with US FDA

On August 10, biopharmaceutical company Gilead Sciences asked the US Food and Drug Administration for the ‘full-time’ approval of its experimental drug remdesivir that improved recovery in COVID-19 patients. The company was granted the emergency use authorization (EUA) earlier in May after researchers found it reduced the mortality rates among 312 people hospitalized from COVID-19 disease, according to its Comparative Analysis of Clinical Recovery and Mortality Outcomes study published for its Phase 3 SIMPLE Trial. 

In a press release, the pharmaceutical company said that it submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Veklury’s (Remdesivir) approval. It added the application was in the final tier of the NDA submission that was initiated on April 8, 2020. Currently available widely in the US, the investigational antiviral drug is being administered on the patients in the Intensive Care Unit with severe COVID-19 respiratory symptoms. 

Since the beginning of the pandemic, Gilead has worked with urgency to establish the efficacy and safety profile of Veklury, and we now have a robust data set supporting the evaluation of the use of the drug across a range of hospitalized COVID-19 patient populations, said Merdad Parsey, MD, Ph.D., Chief Medical Officer, Gilead Sciences.

Today’s filing is an important milestone as we continue to partner with the U.S. government and healthcare authorities around the globe to address the treatment needs of patients with COVID-19, he added.

Read: UK’s Hikma Starts Manufacturing remdesivir for Gilead For COVID-19 Treatment

Read: Gilead Sciences Says remdesivir Reduces Risk Of Death In COVID-19 Patients

Investigational drug in the US

Gilead’s filing was based on Phase 3 randomized, placebo-controlled study conducted by the National Institute of Allergy and Infectious Diseases (NIAID) that proved remdesivir was associated with drastic symptoms improvement and reduction in the risk of mortality compared with placebo. The results were seen within 5-day or 10-day treatment. The drug has been approved for emergency use in several nations worldwide, including the European Union and Japan. However, in the US, Veklury is an investigational drug and the safety and efficacy of remdesivir have not been established, according to the company’s release. 

Read: FDA Grants Remdesivir Emergency Use Authorisation To Treat COVID Patients, Announces Trump

Read: Study: Remdesivir Improves Recovery Time In COVID-19 Patients