Remdesivir, check. Now, analysts are looking ahead to 'several' COVID-19 drugs to come

Gilead Sciences scored an FDA emergency nod for remdesivir in COVID-19 on Friday. (Gilead Sciences)

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.


De-risking the Development of Biotherapeutics Using Early Stage In Vitro Expression and Genetic Characterisation Tools

Wednesday, July 8, 2020 | 11am EST / 8am PST

This webinar will describe strategies to mitigate risks, reduce attrition and help improve the quality and safety of your drug candidate.

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.

RELATED: Gilead's remdesivir speeds COVID-19 recovery in first controlled trial readout, but it's no 'silver bullet'

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.

RELATED: Gilead CEO: Remdesivir could be the benchmark for COVID-19 drug development

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.

Suggested Articles

Johnson & Johnson has expanded its COVID-19 vaccine production pact with CDMO Catalent to include work at the manufacturer's Anagni, Italy site.

German vaccine maker CureVac scored an $85 million EU loan to expand manufacturing for its mRNA-based COVID-19 vaccine hopeful.

Learn how drug substance and drug product early development strategies are important for optimization and long-term success.