Veklury obtains FDA approval for COVID-19 outpatients
pharmafile | January 24, 2022 | News story | Sales and Marketing |
The FDA has granted expedited approval of a supplemental new drug application (sNDA) for Veklury (remdesivir) for he treatment of non-hospitalised adult and adolescent patients who are at increased risk of progression to severe disease, including hospital admission and death.
The expanded indication allows for the drug to be administered in qualified outpatient settings that can administer daily intravenous (IV) infusions over three consecutive days.
Remdesivir, manufactured by Gilead Sciences, was among the first treatments for coronavirus authorised in 2020. The drug received full agency approval later that year for people aged 12 years and older.
The FDA has also expanded the paediatric Emergency Use Authorisation (EUA) of Veklury to include non-hospitalised paediatric patients younger than 12 years of age, who are at high risk of disease progression.
The treatment is currently approved or authorised for temporary usage in nearly 50 nations around the globe. Veklury and generic remdesivir have been made available to over 10 million patients around the world.
“Remdesivir has now helped to treat more than 10 million people around the world with Covid-19 and continues to play a key role in helping to reduce the burden of the pandemic. Based on the most recent data, we now understand that remdesivir is also effective in the early stages of Covid-19 infection, in addition to helping patients who are hospitalized with the disease,” said Daniel O’Day, chairman and chief executive officer, Gilead Sciences. “While we continue to advance remdesivir to benefit more patients in multiple settings, we are also advancing our investigational oral compounds. These are based on the same antiviral mechanism of action as remdesivir and a phase 1 trial for our oral Covid-19 antiviral, GS-5245 is now underway.”
The latest developments are based on findings from the double-blind, randomised, placebo-controlled Phase III PINETREE clinical trial, that analysed the safety and efficacy of Veklury. According to the results, Veklury, provided a statistically significant decline of 87% in the risk of composite primary endpoint of COVID-19-accosiated hospital admission, or all-cause mortality by day 28 versus placebo.
Ana Ovey
