The US Food and Drug Administration’s (FDA) tentative approval earlier this week of a generic form of lenacapavir made by Indian manufacturer Dr. Reddy’s Laboratories is welcome news, but people in dozens of countries will still be locked out of affordable access because of Gilead’s licensing restrictions, said Doctors Without Borders/Médecins Sans Frontières (MSF) today.
Lenacapavir is a highly effective, twice-yearly injectable form of HIV prevention. Gilead Sciences, the US-based pharmaceutical corporation that makes lenacapavir, has given six manufacturers permission to produce generic versions, but those deals bar their sale in 26 low- and middle-income countries. Dr. Reddy’s has agreed to sell its version for $40 per person per year compared to the more than $28,000 per person per year that Gilead sells it for in the US.
Carlota Baptista, MSF’s global lead for HIV & HCV (Hepatitis C) access and advocacy, said today:
“The FDA approval of a generic version of lenacapavir is an important milestone for HIV prevention. It brings us a step closer to generic competition and wider availability of this groundbreaking medicine at affordable prices.
“But regulatory approval does not put the drug in people’s hands, and it does not guarantee equitable access. Twenty-six low- and middle-income countries remain excluded from the anticipated $40 per person per year generic price because of the restrictive terms of Gilead’s licensing agreements.
“The countries currently excluded from Gilead’s deals include some with growing HIV epidemics, including much of Latin America, a region where new infections have risen by 25 percent since 2010.
“MSF teams have already seen the consequences of limited supply and price barriers of lenacapavir worldwide. Affordable generics could help address access gaps and make sure that more people living in humanitarian settings like those in which MSF operates can be protected against HIV.
“Now Gilead must allow all countries to take advantage of generic versions of lenacapavir. If it is unwilling, governments must step in to help increase access and protect more people from acquiring HIV.”
