Nov. 16 Quick Takes: Pfizer requests EUA, enters patent pool

If FDA’s review timeline for the oral COVID-19 antiviral from Pfizer Inc. (NYSE:PFE) follows the pattern of molnupiravir from Merck & Co. Inc. (NYSE:MRK), the Pfizer pill could gain emergency use authorization early next year. Eleven days after reporting efficacy data from a Phase III study of Paxlovid (PF-07321332), Pfizer said a rolling submission to FDA began last month now includes a request for the EUA. Days after Merck’s Oct. 11 submission, FDA scheduled an advisory committee meeting for Nov. 30 to discuss the EUA request; since Pfizer is trailing Merck by about five weeks, FDA could convene a meeting for Pfizer’s pill shortly after the first of the year. FDA has granted EUAs to COVID-19 interventions swiftly after advisory panels during the pandemic.

Pfizer also announced Tuesday that it agreed with the Medicines Patent Pool to enter a voluntary license for Paxlovid that will enable the U.N.-backed organization to facilitate access to the antiviral in combination with ritonavir in 95 countries, comprising 53% of the world’s population, by granting sub-licenses to generics makers. The regions include all low- and lower-middle-income countries and some upper-middle-income countries in Sub-Saharan Africa, plus countries that have gained upper-middle-income status in the past five years. The pharma will not receive royalties on sales in low-income countries and will waive royalties in all countries under the deal as long as WHO classifies COVID-19 as a Public Health Emergency of International Concern...