The Medicines Patent Pool (MPP) announced sublicensing agreements with seven manufacturers to produce and distribute generic versions of Japanese pharmaceutical company Shinogi’s COVID-19 antiviral treatment in 117 low- and middle-income countries. 

Ensitrelvir is an oral antiviral currently only approved in Japan under the country’s emergency regulatory approval system. The drug is being evaluated under a fast-track designation by the US Food and Drug Administration, and its regulatory authorization is still pending in all the 117 countries listed in the license agreement. 

“Even though COVID-19 is no longer classified as a Public Health Emergency of International Concern, we see numbers ebb and flow across continents as we learn to live with the disease,” said Charles Gore, Executive Director of MPP. “Having quality effective treatments readily available in LMICs is still so important.” 

The absence of regulatory approval for Shinogi’s drug stands in contrast to Paxlovid, a similar oral antiviral rolled out by Pfizer in the early months of the pandemic. Paxlovid has been available under emergency authorization in the United States since December 2021, which was followed a month later by the European Union. Full marketing approval was granted by both the US and EU in the first half of 2023. 

Ensitrelvir has a steep hill to climb

MPP signed sublicensing agreements to manufacture and distribute Paxlovid in 95 low- and middle-income countries in November 2021. Under the terms of the agreement, Pfizer abstained from royalties on sales as long as COVID-19 remained classified as a Public Health Emergency of International Concern.

The WHO’s declaration of the end of the COVID-19 public health emergency in May changed the terms, but not by much. Pfizer became entitled to a 5% royalty fee on sales to the public sector in lower-middle-income and upper-middle-income countries. Low-income countries, however, can still purchase Paxlovid without paying royalties. 

Ensitrelvir still has a steep hill to climb if it is to make an impact. But for communities on the ground in LMICs, the prospect of having access to another treatment is good news. 

“Through my work, I support two sisters who lost their parents to COVID-19 at the height of the pandemic. In our communities, such loss goes beyond the terrible grief as the young adolescents have been left to fend for themselves at a vulnerable age,” said Nombeko Mpongo of the Desmond Tutu HIV Center in South Africa. 

“Access to treatment is so much more than a question of life and death, it is about the well-being of entire communities,” he said. “I welcome this announcement that will enable equitable access to COVID-19 treatments in my country and other LMICs.”