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31 March 2020Big PharmaRory O'Neill

Gilead expands special access to potential COVID-19 drug

Gilead Sciences says it is expanding access to its experimental antiviral remdesivir for treatment of COVID-19, albeit on a limited basis.

The drug has emerged as the most promising candidate for an effective coronavirus treatment, with several clinical trials already underway and initial results being published potentially as soon as next month.

Gilead has so far made the drug available in the US on “compassionate use” grounds, meaning a new, unapproved drug can be given to a patient where there are no other options available.

But the company says the FDA’s compassionate use programme is not designed to cope with the numbers of applications it has been receiving for remdesivir in the wake of the COVID-19 pandemic.

Gilead is now restricting compassionate use of remdesivir to children and pregnant women, while also rolling out “expanded use” on request of doctors and hospitals.

The difference is that whereas compassionate use is reviewed on an individual case-by-case basis, expanded use allows doctors and hospitals to make requests for multiple severely ill patients at a time.

While the new programme will take time to establish, Gilead says it will ultimately result in more COVID-19 patients having access to the drug.

Politicians and activists have expressed concern over the prospect of Gilead having a monopoly over remdesivir. The company was accused of abusing the ‘ orphan drug’ designation system, which is intended to incentivise the development of drugs for rare diseases.

Gilead announced last week that it had asked the FDA to rescind ‘orphan drug’ status, which carries benefits such as seven years of marketing exclusivity and tax breaks, for the drug.

In a statement, the company said it was confident that it could “maintain an expedited timeline in seeking regulatory review of remdesivir without the orphan drug designation”.

Presidential candidate Bernie Sanders demanded that President Trump stop the “corporate giveaway” to Gilead, which also received public funding to help develop the drug.

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More on this story

Big Pharma
26 March 2020   Gilead Sciences has agreed to drop the lucrative “orphan drug” designation for an antiviral touted as a potential coronavirus treatment, after criticism from activists and politicians including Bernie Sanders.
Big Pharma
2 April 2020   Almost 150 health and poverty activist campaigns, including Médecins Sans Frontières, have urged Gilead Sciences to waive patent and exclusivity rights for potential COVID-19 treatment remdesivir.

More on this story

Big Pharma
26 March 2020   Gilead Sciences has agreed to drop the lucrative “orphan drug” designation for an antiviral touted as a potential coronavirus treatment, after criticism from activists and politicians including Bernie Sanders.
Big Pharma
2 April 2020   Almost 150 health and poverty activist campaigns, including Médecins Sans Frontières, have urged Gilead Sciences to waive patent and exclusivity rights for potential COVID-19 treatment remdesivir.