Regeneron has requested an emergency clearance from the Food and Drug Administration for its experimental antibody drug for COVID-19, hours after rival Eli Lilly took a similar step.
Regeneron didn’t say exactly which group of COVID-19 patients it’s asking for approval to treat. But early study results suggested its treatment is best suited for patients with mild symptoms who have high levels of virus and who aren’t yet mounting an immune response to infection, characteristics that would have to be determined through testing.
Coronavirus antibody drugs have gained in notoriety since Regeneron’s treatment, among other medicines, was used to treat President Donald Trump last week. Trump indicated in a video Wednesday evening that an emergency clearance is imminent for both Eli Lilly and Regeneron, though Lilly’s chief executive said earlier that a thorough and adequate review “inevitably takes time.”

A day that began with Lilly bringing the first COVID-19 antibody drug to the FDA ended with its chief competitor quickly following suit and President Trump, without evidence, touting the treatments as a “cure.”

Their momentum, and their use in Trump’s treatment regimen, has put the drugs in the national spotlight alongside coronavirus vaccines. And indeed, their help in slowing the pandemic could be crucial, if early results showing Eli Lilly’s and Regeneron’s treatments can keep some people out of the hospital and reduce symptoms hold up in further testing.

But their impact may still not be felt for some time, as supplies are currently limited. The drugs are complex to manufacture and initial clearances, if they come, will likely to be for specific groups of patients. The current COVID-19 antibodies are also infused in an outpatient setting, making widespread adoption more difficult.

Eli Lilly, for instance, is aiming for an emergency approval in higher-risk patients with mild-to-moderate COVID-19, a term that hasn’t been defined by regulators but that the company aims to tie to age and elevated body-mass index.

Regeneron didn’t say who its initial approval request would target, though it’s aiming to confirm findings that appear to show the biggest benefit in patients with a lot of virus in their blood and little detectable antibody response to infection. Tests in other groups — like hospitalized COVID-19 patients or people who have been exposed to the virus but haven’t showed symptoms yet — are ongoing. The preventive studies, in particular, will take longer to produce results since investigators have to wait for events like hospitalizations to occur.

Manufacturing, meanwhile, remains one of the biggest limitations for antibodies, in part because the companies haven’t received nearly the level of financial support as have vaccines.

Regeneron’s initial doses are largely being paid for through a $450 million contract with the U.S. government through the Trump administration’s Operation Warp Speed initiative. The sum, while sizable, is much less than OWS vaccine contracts, and no other antibody developer has received a supply deal.

Even with the government’s help, Regeneron won’t be able to deliver millions of doses until 2021. The company currently has enough supply for 50,000 patients, and expects to produce enough for 300,000 people by the end of the year.

Lilly, meanwhile, said it could supply about 1 million doses of its treatment this year, with 100,000 available this month. The company on Thursday announced a deal with the Bill & Melinda Gates Foundation to help deliver its antibodies to low- and middle-income countries, with commercial manufacturing beginning next year.

It’s also unclear what the treatments will cost. Trump, in a video posted Wednesday evening, said that patients in the U.S. would get the drugs for free. While Lilly CEO Dave Ricks said Wednesday that the company’s hope was patients would “have no or very, very low out of pocket costs,” he did note wealthy countries would be charged more than poorer ones. Lilly didn’t commit to providing the treatment at no profit.

“Whatever we end up charging, it should create value for society beyond Lilly,” Ricks said.

Doses of Regeneron’s treatment that have been procured by the U.S. government would be provided for free, but the company said in an emailed statement it hadn’t determined its plans beyond that initial supply.

Regeneron’s treatment consists of two antibodies that latch on to different areas of the coronavirus, an approach that’s meant to prevent viral escape and account for possible genetic variants in the virus. Lilly is developing both a single antibody and a combination treatment similar to Regeneron’s. The monotherapy was the one Lilly submitted for emergency clearance, though the pharma expects to follow with a request for its other regimen in November.

Other COVID-19 antibody drugs from AstraZeneca and from partners Vir Biotechnology and GlaxoSmithKline are also in human testing.