Friday, November 5, 2021

Molnupiravir may become the first COVID-19 pill. What took so long?

By Lisa Larrimore Ouellette, Nicholson Price, Rachel Sachs, and Jacob S. Sherkow

On October 1, the developers of the COVID-19 antiviral molnupiravir issued a press release announcing positive Phase 3 clinical trial results, with a 50% reduction in the risk of hospitalization or death. On November 4, the UK’s Medicines and Healthcare products Regulatory Agency authorized molnupiravir for use in the UK. While the results have yet to be reviewed by a scientific journal, they have generated excitement not only because of the potential lives saved but also because molnupiravir can be taken orally in tablet form, greatly reducing the difficulty and cost of administration. (Monoclonal antibodies require intravenous administration, as do the less promising treatments remdesivir and plasma therapy.) While it remains to be seen whether molnupiravir is as effective a weapon as its namesake Mj√∂lnir (Thor’s hammer), the news so far is promising. But why, in a global pandemic where vaccines could be pushed through in record-breaking time, were new treatments like molnupiravir so much slower to find? (It’s worth noting that molnupiravir isn’t the only drug in this situation; as this post was going to press on November 5, Pfizer announced that its experimental antiviral, Paxlovid, reduced COVID-19-related hospital admissions for high-risk adults by 89%.)

In this post, we explore the role of innovation policy in molnupiravir’s development, the FDA’s role in balancing access to promising treatments with the need to generate evidence of their efficacy, questions about molnupiravir access, and the implications for antiviral innovation going forward, for COVID-19 and beyond.