The FDA granted remdesivir an emergency use authorisation for the treatment of hospitalised patients with severe Covid-19
California: US-based biopharmaceutical major Gilead Sciences will soon start clinical trials for inhaled formulation of its anti-viral drug remdesivir used for the treatment of Covid-19.
"After receiving the green light from the Food and Drug Administration to move forward, Gilead is about to start trials of an inhaled version of remdesivir," said Chairman and CEO Daniel O'Day.
"We will screen healthy volunteers for phase one trials this week and hope to begin studies in patients with Covid-19 in August. If the trials are successful, this could represent important progress," he said in a message posted on the company's website.
Remdesivir, the investigational anti-viral medicine, is currently given to patients intravenously through daily infusions in the hospital. An inhaled formulation will be given through a nebuliser which could potentially allow for easier administration outside the hospital at earlier stages of disease.
"That could have significant implications in helping to stem the tide of the pandemic," said O'Day. "As part of our next wave of clinical development, we will study remdesivir in treating earlier in the disease, in combination with other therapies and in additional patient groups."
O'Day said as part of the aim to benefit as many patients as possible, Gilead Sciences is focused on ensuring sufficient supplies of remdesivir and enabling access.
"We now expect to have more than two million remdesivir treatment courses manufactured by the end of the year and many millions more by 2021. Our scientists will stay focused on optimising the manufacturing process, and we will continue to collaborate globally to ensure sufficient worldwide supply."
Remdesivir is an anti-viral product that is being studied in multiple ongoing international clinical trials. It has not been approved by the US FDA for any use.
In the United States, the FDA granted remdesivir an emergency use authorisation for the treatment of hospitalised patients with severe Covid-19. This authorisation is temporary and may be revoked, and does not take the place of the formal new drug application submission, review and approval process.