Antivirals and antibody therapies are showing promise. The FDA needs to step up its pace.
Some imagine that the coronavirus will run its tragic course in the spring, with the direst results avoided by intense social-distancing and other mitigation efforts, and then our lives can more or less return to normal in the summer.
But that isn’t realistic. Even if new cases start to stall in the summer heat, the virus will return in the fall, and so will fresh risk of large outbreaks and even a new epidemic. People will still be reluctant to crowd into stores, restaurants or arenas. Schools may remain closed. The public’s fears won’t relent simply because there are fewer new cases. We’ll be running an 80% economy.
The only way out is with technology. Aggressive surveillance and screening can help warn of new infection clusters that could turn into outbreaks, but that won’t be enough. A vaccine could beat the virus, but there won’t be one this year. The best near-term hope: an effective therapeutic drug. That would be transformative, and it’s plausible as soon as this summer. But the process will have to move faster.
Americans would have the confidence to return to work, even if the virus is still circulating in the fall, if they knew that a robust screening system is in place to identify and arrest new outbreaks and medication can significantly reduce the chance of becoming severely ill. Kevin Warsh, a former Federal Reserve governor, estimates that such a drug could restore at least $1 trillion in economic activity.
Given the enormous public-health and economic stakes, it is worth doing whatever it takes to move such a drug to market. There are two promising approaches, and both could be available soon if government and private industry do things right. It’s time to place some firm bets and put resources behind these experimental treatments.
One approach involves antiviral drugs that target the virus and block its replication. Think of medicines for treating influenza, HIV or cold sores. The drugs work by blocking the mechanisms that viruses use to replicate. Dozens of promising antiviral drugs are in various stages of development and could be advanced quickly. The one furthest along is remdesivir, from Gilead Sciences. There’s evidence from clinical experience with Covid-19 patients that it could be effective.
The other approach involves antibody drugs, which mimic the function of immune cells. Antibody drugs can be used to fight an infection and to reduce the risk of contracting Covid-19. These medicines may be the best chance for a meaningful near-term success.
Antibody drugs are based on the same scientific principles that make “convalescent plasma” one interim tactic for treating the sickest Covid-19 patients. Doctors are taking blood plasma from patients who have recovered from Covid-19 and infusing it into those who are critically ill. The plasma is laden with antibodies, and the approach shows some promise. The constraint: There isn’t enough plasma from recovered patients to go around.
Antibody drugs are engineered to do the same thing as convalescent plasma, but because they’re synthesized, they don’t depend on a supply of antibodies from healed patients. Biotech companies would manufacture them in large quantities using recombinant technology, the same approach behind highly effective drugs that target and prevent Ebola, respiratory syncytial virus and other infections. The antibodies can also be a prophylaxis given to those exposed to Covid-19, or to prevent infection in vulnerable patients, such as those on chemotherapy. These drugs could protect the public until a vaccine is available.
The biotech company Regeneron successfully developed an antibody drug to treat Ebola as well as one against MERS, a deadly coronavirus similar to Covid-19. Regeneron has an antibody drug that should enter human trials in June. Vir Biotechnology is also developing an antibody treatment for Covid-19 and says it could be ready for human trials this summer. Amgen recently started its own program with Adaptive Biotech and Eli Lilly has one as well. If these approaches work, the drugs can advance quickly, because much of the science and the safety is already well understood.
But success will require a strong sense of urgency from manufacturers—and from regulators, who need to collaborate with drug developers in innovative ways to move the most promising therapies. The Food and Drug Administration has deployed tactics in recent years to advance therapeutics aimed at rare and deadly cancers. One is real-time reviews, in which regulators work with drug developers to evaluate data as it is read out from clinical trials, instead of waiting until the trial concludes, to understand the potential benefits and risks rapidly. This has enabled drug developers to accelerate development timelines. FDA’s senior career scientists need the firm backing of political leadership to apply these and similar scientific approaches to Covid-19.
Americans’ lives won’t return to normal absent a technological breakthrough. But with some effort, American industry and government can before this fall produce therapies that save lives and restore freedom and prosperity.
Dr. Gottlieb is a resident fellow at the American Enterprise Institute and was commissioner of the Food and Drug Administration, 2017-19. He serves on the boards of Pfizer and Illumina and is a partner at the venture-capital firm New Enterprise Associates.
