Foster City, CA—Inhaled, and potentially, oral dosage forms of remdesivir could become available at some point to be prescribed to COVID-19 patients recovering at home.

Remdesivir is currently approved in Japan as a treatment for patients infected with SARS-CoV-2, the virus that causes COVID-19. Outside of Japan, remdesivir is an investigational, unapproved drug. While the FDA has granted remdesivir an Emergency Use Authorization for the treatment of hospitalized patients with severe COVID-19, that authorization is temporary and does not take the place of the formal New Drug Application submission, review, and approval process.

Now, the drug’s manufacturer says that it is looking to create forms of the drug that can be used, pending approval, on an outpatient basis.

A report in the New England Journal of Medicine in May concludes that the broad-spectrum antiviral medication developed by the biopharmaceutical company Gilead Sciences was superior to placebo in shortening the time to recovery in adults hospitalized with COVID-19 and who had evidence of lower respiratory tract infection.

Gilead also has had promising results with a shorter, 5-day course of the medication and is looking to create versions that can be used in patients who do not require hospitalization.

“If a five-day dosing duration is shown to be safe and effective, this would increase the number of patients who could be treated with the current supply projections,” the company has said in a press release. “Our researchers are also looking at the future potential for developing inhaled and potentially oral dosage forms of remdesivir to help alleviate the need for hospital administration of the drug.”

The company says that it has proactively and rapidly scaled its supply chain, explaining, “As of late March, using the active ingredient we already had in our inventory, we have increased our supply to more than 30,000 patient courses of remdesivir on hand, assuming a 10-day course of treatment for patients. As new raw materials arrive over the next few weeks from manufacturing partners around the world, our available supply will begin to rapidly increase.”

With a previous goal of more than 140,000 treatment courses by the end of May, Gilead says that it is now shooting for more than 500,000 treatment courses by October 2020 and more than 1 million treatment courses by December 2020. It emphasizes that the numbers are based on a 10-day treatment course, but the supply could be much greater if the SIMPLE study confirms that a 5-day course would suffice.

“While cases of COVID-19 continue to increase, only a portion of patients experience severe symptoms that may make them appropriate candidates for treatment with remdesivir,” notes the press release. “Patients currently receiving remdesivir through clinical trials or expanded access are hospitalized and have moderate to severe manifestations of COVID-19, such as early respiratory failure. According to the World Health Organization, approximately 14% of patients with COVID-19 will experience severe manifestations of the disease that require hospitalization and supplemental oxygen, and 5% will require treatment in intensive care units. The potential benefits and risks of treatment with remdesivir for COVID-19 are not yet fully known.”

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