Regeneron leaps ahead in COVID-19 antibody race, scoring FDA nod for lower dose and subcutaneous injection

regeneron
In addition to allowing Regeneron to administer its antibody drug by injection, as opposed to intravenous infusion, the FDA will allow the cocktail to be stored in a single vial. Previously, it was supplied in two vials and mixed before it was administered. (Fierce Pharma)

When Eli Lilly gained emergency use approval for its COVID-19 antibody treatment last October, it was a major triumph for a company aiming to satisfy a desperate need around the world.

But eight months later, the loser of that race to the FDA finish line, Regeneron, is gaining steam with its Roche-partnered antibody as Lilly struggles to keep its treatment relevant. 

Friday brought news that the FDA has made Regeneron’s monoclonal antibody cocktail more user friendly, allowing it to be administered by subcutaneous injection in addition to its original administration form of intravenous infusion. The agency also approved a lower dose of the Regeneron drug, 1200 mg, allowing the company and officials to stretch available supply.

So far in the rollout, though, supply hasn't been the primary issue. Since the drug combo is administered by infusion but is only authorized for patients with mild to moderate symptoms, many eligible patients aren't in the healthcare facilities where it can be given. 

“Unfortunately to date only a fraction of patients eligible for antibody treatments have received them, which we hope will change based on this updated FDA authorization,” Regeneron’s chief scientific officer George Yancopoulos, M.D., said in a statement.  

RELATED: Regeneron eyes prevention nod for COVID-19 antibody cocktail with simpler injection

Intravenous infusion of REGEN-COV is still recommended under the FDA's emergency authorization. The new action just provides for a more convenient option for clinics and hospitals. The treatment is for non-hospitalized patients who have contracted COVID-19 and are at a high risk for progression to a more severe form of the disease.

The FDA action came after a phase 3 trial showed no difference in the drug’s 70% efficacy rate between the 1200 mg and 2400 mg doses.

The adjustment for Regeneron’s treatment comes a week after bad news for Lilly's rival combo. Last week, the feds halted distribution of the Lilly drug combo in six states, including California and Florida, where concerning coronavirus variants account for more than 10% of cases. The treatment, a combination of bamlanivimab and etesevimab, had already been halted in Illinois and Massachusetts for the same reason. Officials say evidence show the Lilly combo could be susceptible to variants, while the Regeneron combo continues to hold up.

RELATED: Eli Lilly’s COVID-19 antibody halted in 6 more states as Regeneron’s competing option sails along 

Last week the FDA approved another COVID-19 antibody treatment, this one from GlaxoSmithKline and Vir. But the companies have yet to secure a supply deal with the U.S.

Regeneron plans to supply the U.S. with 1 million antibody doses this quarter and expects to provide an additional 1.25 million doses in the third quarter.