Gilead Sciences Inc.

10/03/2024 | Press release | Distributed by Public on 10/03/2024 09:16

Gilead Donates Remdesivir for Emergency Use in Response to Marburg Virus Disease in Rwanda

Foster City, Calif., October 3, 2024 - Gilead announced today that it will donate approximately 5,000 vials of remdesivir to the Rwanda Medical Supply in conjunction with the Ministry of Health of the Republic of Rwanda and the Africa Centers for Disease Control for emergency use in response to the Marburg Virus Disease (MVD) outbreak.

"The recent Marburg outbreak in Rwanda is one of the largest in history and while the country has built a strong public health system, filoviruses like Marburg can lead to significant morbidity and mortality," said Anu Osinusi, Vice President of Clinical Research for Hepatitis, Respiratory and Emerging Viruses, Gilead Sciences. "With Gilead's broad experience in virology, we are committed to helping support the response to this outbreak as efficiently as possible. Our immediate focus is working closely with government and health authorities to provide access in Rwanda to remdesivir for emergency use."

Remdesivir is being provided for the treatment of MVD in Rwanda following the authorization for emergency use by the Rwanda Food and Drugs Authority (Rwanda FDA). Remdesivir is not approved for the treatment of MVD anywhere globally, and the safety and efficacy of this use is not known.

The Ministry of Health of the Republic of Rwanda declared a MVD outbreak on September 27, 2024. MVD is a severe and often fatal illness caused by the Marburg virus, which is a member of the filovirus family, similar to the Ebola virus. The disease has a high mortality rate, reaching up to 88% in outbreaks depending on virus strain and case management. There are no treatments or vaccines approved for MVD, but there are investigational ones in development.

"Gilead has a legacy of responding to some of the world's most devastating health crises - from our work in HIV to our swift mobilization to enable broad emergency use access to remdesivir in the early days of the COVID-19 pandemic. I'm proud that our teams are once again responding quickly and decisively to this emerging crisis in Rwanda," said Johanna Mercier, Chief Commercial Officer, Gilead Sciences. "We will continue to partner closely with the Rwanda Ministry of Health and other local and global groups and we're hopeful that early intervention and treatment with remdesivir could be helpful in responding to this Marburg outbreak."

Remdesivir is a nucleotide analog prodrug invented and developed by Gilead, building on more than a decade of the company's antiviral research. Remdesivir has broad-spectrum antiviral activity both in vitro and in animal models against multiple viral pathogens, including Marburg, Ebola, SARS, MERS and SARS-CoV-2, the virus that causes COVID-19.

Remdesivir has been approved as a COVID-19 treatment in approximately 50 countries worldwide. To date, remdesivir has been made available to more than 14 million patients around the world, including more than 8 million people in middle- and low-income countries through Gilead's voluntary licensing program.

The clinical efficacy of remdesivir for MVD remains to be established. This emergency use donation is based on the preclinical data for Marburg virus together with extensive clinical safety data from the use of remdesivir for the treatment of COVID-19.

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