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UPDATED: Gilead drops remdesivir’s orphan drug designation

Decision comes amid intense public criticism of the regulatory status


UPDATED 26 MARCH 2020: Following intense criticism from a number of sides, Gilead has made the decision to drop its orphan drug designation for its potential coronavirus treatment remdesivir, only two days after gaining the status from the US Food and Drug Administration (FDA).

Gilead had maintained that at the time that it had filed for the designation – which awards companies with patent exclusivity for seven years – the coronavirus outbreak was nowhere near the level of severity it is at now.

Even so, critics accused the big pharma company of profiteering off of the global pandemic, as orphan drug designation also comes with tax incentives aimed at encouraging the development of drugs for rare diseases.

Responding to the designation, consumer group Public Citizen said in a letter to Gilead CEO Daniel O’Day: “This is an unconscionable abuse of a programme designed to incentivise research and development of treatments for rare diseases.”

“Calling COVID-19 a rare disease mocks people’s suffering and exploits a loophole in the law to profiteer off a deadly pandemic,” it added.

The orphan status also drew the attention of potential Democratic presidential nominee Bernie Sanders, who called the move “truly outrageous”, adding that “now is not the time for profiteering in the pharmaceutical industry”.

Gilead has further defended its decision to seek orphan drug designation for the potential coronavirus treatment, saying that it had sought the status to expedite approval for the drug, in particular for a required paediatric study plan.

“Gilead is confident that it can maintain an expedited timeline in seeking regulatory review of remdesivir, without the orphan drug designation. Recent engagement with regulatory agencies has demonstrated that submissions and review relating to remdesivir for the treatment of COVID-19 are being expedited,” the company said in a statement.

ORIGINAL ARTICLE 25 MARCH 2020: Gilead’s potential coronavirus treatment remdesivir has received orphan drug designation from the FDA, and has swiftly come under fire for it.

An orphan drug designation from the FDA secures seven years of market exclusivity for any treatment which receives the coveted status. This means that Gilead now has an exclusive patent for remdesivir, an experimental antiviral which has been touted as a potentially effective treatment against the novel coronavirus disease COVID-19.

Along with patent exclusivity, orphan drug designations also provide companies with tax incentives and other benefits, which has lead to health activists criticising Gilead for monopolising on the current pandemic.

“This action by Gilead is Big Pharma profiteering at its finest, and shows why we cannot depend on drug companies to show responsible restraint in pricing even in a global emergency,” said David Mitchell, founder of the campaign group Patients for Affordable Drugs (quoted in The Financial Times).

However, Gilead has responded to the criticism by maintaining that it had applied for the status prior to the COVID-19 outbreak becoming a global pandemic, when “only a small number of Americans were affected”.

It added that it is “making significant at-risk investments to develop and manufacture” the drug as the virus spreads at a rapid rate not only in the US, but across the world.

As of 25 March, over 425,000 people have been infected with the novel coronavirus, with almost 19,000 deaths caused by the COVID-19 disease.

Remdesivir, originally developed as a treatment for Ebola virus disease, has been in the global spotlight as the first potential treatment for COVID-19 after previous research showed it had promise against other types of coronavirus – namely MERS and SARS.

Gilead has already initiated a clinical trial of remdesivir in patients with a laboratory-confirmed case of COVID-19 and evidence of lung involvement.

The trial, which is being undertaken in collaboration with the US National Institutes of Health, will not be including patients with COVID-19 that have only mild symptoms.

Gilead has already faced patent challenges to remdesivir in China, after a team of Chinese scientists who allege they have improved and targeted the drug’s use against COVID-19 filed a patent in China.

Chinese pharma company BrightGene also alleged that it had successfully copied remdesivir and had plans to manufacture a generic version of the drug.

However, the company was subsequently censured by the Shanghai Stock Exchange (SSE) for making misleading claims and disclosing inaccurate information over its alleged manufacture of remdesivir.

The SSE said that BrightGene had not gained approval from China’s drug regulator to manufacture the drug, and had also not gained a licence to manufacture the drug on a large scale from Gilead, which owns the patent in China.

Gilead’s decision to gain orphan drug designation for remdesivir strongly contrasts AbbVie’s choice to suspend patent rights to its HIV treatment Kaletra (aluvia), which is also currently being studied for efficacy against COVID-19.

Article by
Lucy Parsons

25th March 2020

From: Regulatory



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