EMA starts rolling review of Gilead’s COVID-19 hope remdesivir

Fresh from a new crop of data suggesting that Gilead’s remdesivir can speed the recovery from COVID-19, the EMA has started a rolling review of the antiviral drug.

The EU regulator said it couldn’t put a timeframe on a possible approval for remdesivir for coronavirus treatment, but it should allow it to complete its review “significantly earlier”. The review kicks off with the data from the ACTT study reported on Wednesday.

The prospects for remdesivir as a coronavirus therapy dominated Gilead’s first-quarter results update yesterday, with the company’s chief executive Daniel O’Day saying it expects to spend up to $1bn on the drug this year.

That spending will go on testing the drug for COVID-19 as well as on manufacturing to produce a million treatment courses of the drug by the end of the year.

It has already pledged to produce 1.5m doses by the end of May, equivalent to around 140,000 treatment courses using a 10-day regimen, but with significantly more if remdesivir can be given for five days only, as indicated by Gilead’s just-reported SIMPLE trial.

“We are donating our entire existing supply because frankly this is the right thing to do at this time amid the human health need in the pandemic,” said O’Day. He added that Gilead is working to build a global consortium of pharmaceutical and chemical manufacturers to expand global capacity and production for remdesivir.

For now, the company is remaining tight-lipped on when it may start charging for the drug and recoup its investment, which would be permitted after emergency-use authorisation.

O’Day told analysts yesterday that “there is no rulebook out there – other than that we need to be very thoughtful about how we can make sure we provide access of our medicines to patients around the globe”.

“We just don't have the answers yet…but we deeply respect and appreciate the fact that when we get into millions of doses, we have to have a sustainable economic model that works here and that achieves access to affordability to patients around the world,” he added.

SVB Leerink analyst Geoffrey Porges said that he believes the drug will have “limited economic value” to Gilead.

Remdesivir took up a large chunk of an extra $100m in R&D spending in the first quarter of the year, but on the whole Gilead was largely unscathed by the pandemic, despite having therapies that might be impacted by reduced doctor-patient interaction during lockdown.

Product sales rose by 5% to $5.47bn overall, with its main HIV business up by nearly 14% to $4.1bn – driven mainly by Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide) which more than doubled to $1.7bn.

Revenues were likely bolstered by stockpiling during the quarter as the coronavirus pandemic gathered pace.