the staff of the Ridgewood blog
Ridgewood NJ, Pfizer announced last week that its investigational antiviral pill to treat COVID-19 reduced the risk of COVID-19-related hospitalization or death from any cause by 89% when compared to a placebo among patients treated within 3 days of symptom onset. The planned interim results come from a Phase 2/3 clinical trial examining the pill—which is called Paxlovid and is taken in combination with an older antiviral named ritonavir—among COVID-19 patients recovering at home who are at high risk of developing severe disease. The company said it plans to submit the data to the US FDA as soon as possible to request emergency use authorization (EUA) for the antiviral. This is the second oral pill that has shown positive results in clinical trials for treating people with COVID-19 at home and could help alleviate the strain of the pandemic on hospitals. The other antiviral, molnupiravir, being developed by Merck and Ridgeback Biotherapeutics, reduced the risk of hospitalization and death by about half, and UK regulators granted conditional authorization to the pill last week. Clinical trial data for both drugs have not yet been peer-reviewed or published in a journal.
Access to any new therapy is a global concern, and Pfizer said it will institute a tiered-pricing approach to promote equitable access if the drug receives regulatory clearance. Merck also has taken steps to facilitate manufacturing and distribution of its antiviral, including entering into advance purchase agreements with individual nations, implementing tiered pricing, and granting voluntary licenses to generic manufacturers and the Medicines Patent Pool. Notably, wealthy nations are already contracting with both companies for supplies of the antivirals, raising questions about when low- and middle-income countries (LMICs) might be able to access the treatments, with limited supply expected to be produced through the end of the year.