- The Food and Drug Administration on Friday broadened its approval of Gilead's COVID-19 drug Veklury to include people who haven't yet been hospitalized, a move meant to help bolster the supply of drugs available to counter the omicron variant.
- Veklury was originally approved in the U.S. in October 2020 for patients who are at least 12 years old and hospitalized with COVID-19, making the drug part of standard treatment for people with severe disease. The new approval makes Veklury an option for those with mild or moderate symptoms as well.
- With the expanded label, Gilead's drug becomes an alternative to the synthetic antibody drugs and antiviral pills that can keep people out of the hospital, although its more logistically complex as it's infused over multiple days. Veklury substantially reduced the risk of hospitalization in a Phase 3 trial, though Gilead stopped the study early due to enrollment issues.
Two years after Gilead's drug first emerged as an option against COVID-19, Veklury is back in the spotlight.
Originally developed as a medicine for hepatitis C and Ebola, Veklury became the first drug proven effective in treating COVID-19. It is still the only coronavirus medicine with a standard approval from the FDA. (Others are authorized for emergency use.) Sales of Veklury have earned Gilead more than $7 billion since the drug was first granted an emergency clearance in May 2020.
Those sales have come despite substantial limitations that limit Veklury's usefulness. The drug has to be infused over five or 10 days for those with severe disease, and is only modestly effective at speeding their recovery. The FDA was widely scrutinized for approving Veklury when it did, too, as the drug had just failed to prevent deaths in a large study sponsored by the World Health Organization.
What's more, Gilead essentially gave up on plans to expand use of Veklury infusions last April. Citing problems enrolling patients and the availability of antibody drugs, which require only a single infusion or injection, Gilead stopped a trial in COVID-19 patients at high risk of becoming hospitalized. The drugmaker chose instead to focus on more convenient COVID-19 drugs, such as an inhalable version of Veklury. A Phase 1 trial of an antiviral that works similarly to Veklury is also underway.
The spread of omicron, however, has narrowed the number of treatment options that remain useful, as the variant can evade some antibody drugs. Those that retain potency against omicron, like one from GlaxoSmithKline and Vir Biotechnology, are either in short supply or not yet authorized for use. Availability of Pfizer's and Merck's COVID-19 pills, at least for now, is also extremely limited.
While Gilead ended its trial in mild, high-risk COVID-19 patients early, the data did show Veklury reduced the risk of hospitalization or death from any cause by 87%. Gilead said that laboratory tests indicated the drug would remain effective against omicron.
Approval is meant to "bolster the arsenal of therapeutics to treat COVID-19 and respond to the surge of the omicron variant," the FDA's top drug evaluator, Patrizia Cavazzoni, said in a Friday statement. The agency broadened authorization of Gilead's drug for use in children under 12, too.
But the logistical hurdles remain. In outpatient use, Veklury is administered at an infusion center over three consecutive days, which, while shorter than a course for hospitalized patients, is less convenient than other therapies. Patients also need to be tested and treated early enough after symptoms, a persistent challenge with antibody treatments, which had been underutilized for much of the pandemic.