Gilead made waves on Friday with its emergency FDA approval for remdesivir quickly on the heels of a controlled trial data release. But while it’s an important first step, other COVID-19 medicines will likely be coming down the line, analysts with SVB Leerink wrote.
The drug is just the “first of several” expected medicines to treat COVID-19, SVB Leerink analyst Geoffrey Porges wrote to clients following Wednesday's remdesivir data release. Based on the results, U.S. drug officials moved swiftly to grant the drug an emergency use authorization in hospitalized patients. But the nod wasn’t a “ringing endorsement” of the med’s efficacy, he wrote. While it cut patients’ recovery time by 31% in a controlled trial, it didn't significantly decrease the risk of death.
The FDA gave its emergency authorization because the med's benefits outweigh risks in severe patients, the analysts said.
Beyond remdesivir, Porges and his team believe convalescent plasma and hyperimmune gammaglobulin could "confer possibly greater benefit," but present supply challenges. By the fall, experts will know more about monoclonal antibodies in COVID-19, he added.
Following expected nods for those medicines, "we expect quite a long wait until the next breakthroughs emerge," he added.
Meanwhile, the “biggest surprise” about the remdesivir approval was the “aggressive stance taken by the federal government in terms of controlling the supply and distribution of this medicine," Porges wrote. That’s an “unprecedented” move that’s “considerably heavier handed than we had expected" based on Gilead’s comments earlier in the week.
While it does take Gilead off the hook for any potential distribution problems or tough decisions, it “sets an uneasy precedent,” the analysts wrote. The government didn’t ration Tamiflu during the H1N1 pandemic or HIV medicines during that epidemic, they pointed out. As Gilead scales up supply, the analysts hope to see the distribution restrictions relaxed.
Remdesivir scored the emergency nod as companies across the biopharma industry test existing meds against the virus and work on new R&D programs. Dozens are in testing, including some of the industry's big-selling products. Remdesivir itself was a drug developed as a potential hepatitis C treatment, but failed initial testing. The drug also missed the mark in Ebola.