Odd/Bta

Gilead Drops Remdesivirs Orphan Drug Designation

November 18,2021 10:31 AM
- By Admin

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.