FDA anoints Gilead's remdesivir as the Covid

FDA anoints Gilead's remdesivir as the Covid-19 treatment winner, handing down full approval — despite some deep skepticism

Max Gelman
Associate Editor

Seven months into the Covid-19 pandemic, the race to develop a treatment for the disease that’s proved to be the biggest health crisis in a century has an officially designated winner: Gilead. And they’re picking up the prize — worth billions in peak sales — despite a major study that concluded the drug was no help in reducing the number of people who die from the virus.
The FDA handed down a thumbs-up for remdesivir, the company announced Thursday afternoon, as the drug becomes the first fully approved treatment for Covid-19 in the US. Remdesivir, to be marketed as Veklury, will come with a label for treatment in adults and children older than 12 in Covid-19 cases that require hospitalization.
Gilead CEO Daniel O’Day released the following statement with the news that said, in part:

The speed and rigor with which Veklury has been developed and approved in the U.S. reflect the shared commitment of Gilead, government agencies and clinical trial investigators to advance well-tolerated, effective treatment options for the fight against COVID-19. We will continue to work at speed with the aim of enhancing patient outcomes with Veklury to ensure all patients with COVID-19 have the best chance at recovery.

Investors welcomed the news, as Gilead $GILD stock spiked after hours roughly 3.5% to 4% in the immediate wake of the approval. Credit Suisse analyst Evan Seigerman pegged 2020 sales for the drug at $2.9 billion, with the potential to hit $5 billion next year.

In addition to the green light, regulars have also granted a new emergency use authorization for Veklury for hospitalized children under 12 who weigh at least 3.5 kilograms, or any child weighing between 3.5 and 40 kg where use of an IV is deemed appropriate. The safety and efficacy of Veklury for children younger than 12 who weigh less than 40 kg has not been established, Gilead said.
Gilead noted in its announcement that Veklury is only meant for use in in-patient hospital settings and should be administered by healthcare professionals. The drug is also contraindicated for patients who are allergic to Veklury or any of its components.

Veklury was approved based on three randomized control studies, including the full data from the NI¬AID-sponsored Phase III ACTT-1 trial published on Oct. 8, Gilead said. That study showed a reduction in recovery time by five days in hospitalized Covid-19 patients and by seven days in patients requiring oxygen.

Gilead had previously been granted a partial EUA in early May to treat severe Covid-19, which was later expanded in August to include all hospitalized adults and children after a Gilead-led study showed modest efficacy. That study garnered mixed reactions, however, as a 10-day dosing arm of Veklury didn’t lead to a statistically significant improvement over standard of care.
Additionally, a study led by the World Health Organization showed that Veklury did not have any substantial effect on improving mortality rates, reducing the amount of patients needing ventilators or shortening hospital stays, according to a preprint published last week. WHO researchers said the trial was designed to see how the drugs affected in-hospital mortality.

Their findings didn’t confirm what the NIH had reported from ACTT-1: that the drug had “moderately reduced time to recovery.” In the WHO trial, Veklury had no material effects on ventilation initiation or time to discharge. The FDA made no mention of the study in its full risk/benefit assessment of Veklury’s NDA application; however, it did say that it had considered the trial in an FAQ about the approval posted Thursday. Regulators said since Gilead’s ACTT-1 study was randomized, double-blinded and placebo-controlled whereas the WHO trial was open-label, they found ACTT-1 to be “better suited” in a time to recovery endpoint.

“Based on the findings of the ACTT-1 trial, benefit to patients for Veklury was demonstrated including a shorter time to recovery and better odds of clinical im-provement. The SOL¬I¬DAR¬I¬TY results do not refute these findings of benefit to patients,” the agency wrote.
When the WHO preprint was first reported, Gilead knocked the study in a statement to Endpoints News, saying the company was “concerned” that it hadn’t yet gone through the peer review process.
Gilead has also drawn scrutiny over its pricing of the treatment, charging governments outside the US $2,340 for a 5-day course and $3,120 for American insurers.

Veklury was also one of the drugs given to President Donald Trump when he contracted Covid-19 earlier this month, alongside Regeneron’s experimental antibody cocktail and the steroid dexamethasone. The drug had previously been one of on-ly three treatments to receive an EUA for Covid-19 with hydroxychloroquine and convalescent plasma. The former, an anti-malarial, had its EUA revoked in June.