- The biotech giant that developed the first effective coronavirus treatment is now looking to expand its impact.
- Gilead Sciences CEO Daniel O’Day said Monday that the company would start testing an inhaled version of the antiviral drug remdesivir in August.
- Currently, the drug is given as an intravenous infusion.
- If remdesivir is effective when given through a nebulizer, that “could have significant implications in helping to stem the tide of the pandemic,” O’Day wrote in an open letter.
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Gilead Sciences said Monday that it will start testing an inhaled version of remdesivir, thefirst effective coronavirus treatment.
Remdesivir is currently given as an intravenous infusion, which limits its use to the hospital setting. If remdesivir can be inhaled with a nebulizer instead of infused with an IV, it potentially could be used earlier by people with the coronavirus who aren’t in a hospital. Antivirals are typically more effective at combatting viruses when given earlier.
“That could have significant implications in helping to stem the tide of the pandemic,” Gilead CEO Daniel O’Day wrote Monday in an open letter.
The antiviral drug helped hospitalized coronavirus patients recover more quickly, according to a National Institutes of Health trial. It was the first drug to demonstrate a benefit in treating COVID-19, the disease caused by the novel coronavirus.
Based on those results, the US Food and Drug Administration on May 1 issued an emergency authorization for remdesivir’s use. While it’s not an approval, the authorization allows for more hospitalized patients to receive the drug.
O’Day said US regulators will allow Gilead to start testing inhaled remdesivir in August in healthy volunteers. This first small trial will focus on seeing if the drug is safe and tolerable in humans.
Gilead is planning several trials to expand the use of remdesivir
The $US96 billion California biotech giant also plans to try using IV infusions “in outpatient settings such as infusion centres and nursing homes,” O’Day wrote. The goal with earlier treatment would be to avoid the need for hospitalisation.
And Gilead will also start studying combination therapies where remdesivir is given along with other experimental treatments. This could be particularly helpful given a growing understanding of COVID-19. While the main issue in the earlier stages of the disease is fighting the virus, later on critically ill patients often suffer from a runaway immune response. Their own bodies kick into overdrive and can severely damage their own lungs.
“It is important, therefore, to have tools that can work together to fight both aspects of the disease: an antiviral to target the virus itself and another therapy to tackle the inflammatory response,” O’Day wrote. “We have been keen to explore how remdesivir might work when combined with anti-inflammatory agents, particularly in the most severely ill patients.”
The US National Institutes of Health has already been running a study combining remdesivir with an anti-inflammatory arthritis drug called baricitinib, sold as Olumiant by Eli Lilly.
Further trials will narrow in on specific patient groups where COVID-19 may be significantly different. These include testing remdesivir in children, pregnant women, and patients with end-stage renal disease, O’Day wrote.
“Our continued aim in all our studies is to reflect the diverse demographics of the communities affected, including factors such as race, ethnicity and gender,” he said.
Gilead has yet to announce a price for remdesivir
On supply, Gilead expects to have more than 2 million treatment courses by year’s end. The company donated its existing supply of the medicine to governments across the world. Wall Street analysts and investors are widely expecting Gilead to unveil its commercial plans for remdesivir in the coming weeks.
Company executives have repeatedly emphasised they want to keep the drug affordable and accessible. Drug pricing watchdogs have been sceptical, citing the company’s history with high drug prices for HIV and hepatitis C treatments. One of those groups fears Gilead will exploit its “monopoly control to price-gouge patients.”
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