Home treatment of Covid may be easier soon. Instead of hospitalization, many people suffering from Covid may be able to take a pill to treat their infection.
This exciting news comes from Merck and Ridgeback Biotherapeutics that have worked together to produce this new Covid drug called molnupiravir. These companies just released data that showed molnupiravir reduces hospitalizations by about half. They will soon apply to the Food and Drug Administration for emergency use authorization (EUA), which hastens the usually slow process of approval.
The Wall Street Journal editorial board says this potential wonder drug should have been available much sooner. Since the beginning of the pandemic, doctors have been hoping for an oral antiviral that could prevent recently infected patients from getting sicker. The FDA approved Gilead’s remdesivir for emergency use in hospitalized patients last spring, but the intravenous drug is not available to those not sick enough to be hospitalized.
The National Institutes of Health (NIH) prioritized development of monoclonal antibodies, which have helped many patients, including President Trump. But they are difficult to produce and distribute. Since demand exceeded supply this summer, the feds have rationed treatments (a taste of socialized medicine early). But the FDA and the NIH missed the chance to accelerate antivirals like molnupiravir, which creates errors in the machinery of the virus copying code.
Early clinical trials this spring showed molnupiravir rapidly reduces the amount of virus in patients. The Biden administration signed a $1.2 billion contract for 1.7 million courses this past June. While some critics of the pharmaceutical industry complained about the cost, Merck is spending to develop the treatment and scale up production in anticipation of high demands at its own risk. Merck has also signed licensing agreements with generic manufacturers to accelerate the pill’s availability world-wide. The technology to produce the pills in low-income countries is sufficiently simple to make this possible, unlike with the Covid vaccines. This makes molnupiravir a perfect solution for third-world countries.
Yet the FDA has already shown reticence to approve the drug without Phase 3 trials. It seems the FDA believed this summer that vaccines were sufficient for the immediate future, but the many unvaccinated have proven this strategy a failure. WSJ says molnupiravir would have been very helpful during the Delta variant surge this summer if it were only available. Preliminary results from the Phase 3 trials available, showed 7.3% of at-risk patients who received molnupiravir were hospitalized, and none died within 29 days of treatment. By contrast, 14.1% of placebo recipients were hospitalized or died.
Even better news is that the drug seems to be effective against different variants and is unlikely to produce viral resistance. This makes this a great drug now and in the future, not only in America, but world-wide, especially in those countries where vaccines may be unavailable. It may also reduce transmission and the severity of breakthrough infections.
This new drug highlights two facts about our current drug innovation system. One, we need to do everything possible to encourage R & D in developing new drugs. This highlights what I wrote recently in Undermining Drug Innovation. Two, we need a faster system for approval of these drugs by the FDA. The FDA can make up for the lost time by approving molnupiravir as soon as possible.