Gilead's Veklury expands FDA nod to patients outside the hospital as oral version heads to trial

Gilead Sciences’ Veklury, the first FDA-approved COVID-19 treatment, has extended its reach to patients outside the hospital at a time when effective therapies against omicron are in high demand.

Friday, the FDA approved the drug to treat adults and adolescents at high risk of progression to severe COVID-19 illness. The drug had previously been limited to hospitalized patients.

The expedited go-ahead adds a much-needed new option to the antiviral arsenal for outpatients. Existing antibody drugs from Eli Lilly and Regeneron appear to have lost some power against the fast-spreading omicron variant, leaving few options for the many mild COVID-19 cases treated outside a hospital.

Before the new OK, Veklury, or remdesivir, had become the standard of care for hospitalized patients. In the third quarter of 2021, Veklury sales reached $1.9 billion, bringing the nine-month total to $4.2 billion.

More than 10 million patients around the world had received Veklury at the time, and 3 in 5 patients hospitalized in the U.S. are treated with it, Gilead CEO Dan O’Day said a few days ago at the J.P. Morgan Healthcare Conference. The chief executive also touted Gilead’s ability to meet additional demand, thanks to its investments in ramping up manufacturing.

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A phase 3 trial dubbed PINETREE showed that in high-risk non-hospitalized patients, Veklury slashed the risk of COVID-19-related hospitalization or all-cause death by 87% over placebo.

For patients outside the hospital, Gilead uses a shorter, three-day course of Veklury. The typical treatment duration for hospitalized patients is five days and can be extended to 10 days.

The new approval allows Veklury to be used in outpatients, including at skilled nursing facilities, in home health care and at infusion centers, Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

FDA-authorized COVID-19 antibody therapies, which are mostly infusions, have prepped the treatment infrastructure well for Veklury. They include Regeneron’s REGEN-COV, Lilly’s bamlanivimab and etesevimab, and GlaxoSmithKline and Vir Biotechnology’s Xevudy.

Recent studies in cell cultures suggested that Regeneron’s and Lilly’s offerings are unlikely to offer enough protection against the dominant omicron variant.

Veklury still retains its efficacy against omicron, Gilead has said. The small-molecule drug inhibits the coronavirus’s viral RNA polymerase, which is critical for viral replication. In contrast, the antibody drugs target the virus’s spike protein, which is heavily mutated in the omicron variant.

Still, as the FDA has authorized oral COVID-19 options—especially Pfizer’s highly efficacious Paxlovid— the longer-term need for a more cumbersome infusion like Veklury seems limited.

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Gilead is developing its own oral drug—a remdesivir prodrug dubbed GS-5245—which can quickly turn into remdesivir inside the body. A phase 1 trial of the drug is now underway, O’Day said in a Friday statement. A previous study found a prodrug of remdesivir was effective at neutralizing coronavirus in ferrets, blocking virus replication and preventing transmission to other animals.

Speaking to oral remdesivir’s potential competition with Paxlovid, Gilead Chief Medical Officer Merdad Parsey, M.D., Ph.D., said combination therapies could be the future of COVID-19 treatment to combat potential drug resistance. Paxlovid includes a protease inhibitor, which targets an enzyme key in viral replication before RNA replication.

“We’re going to need multiple mechanisms out there to be able to treat [COVID-19] outpatients,” Parsey said during a JPM presentation. “We really think it’s an ‘and,’ not an ‘or.’”