Merck Expands Access to Pediatric Version of HIV Drug Isentress

March 2, 2015

Merck signed an agreement with the Medicines Patent Pool opening the door to lower-cost pediatric versions of its HIV drug Isentress in 92 countries with high rates of HIV infection.

The royalty-free license , which runs through Oct. 31, 2022, allows generics makers around the world to produce and sell Isentress in its current forms — chewable tablets or oral suspension — and develop new formulations for children between four weeks and 12 years of age.

The majority of countries covered by the license are in and around Africa, with a significant number also in continental Asia, the South Pacific and the Americas. One is in Europe.

Isentress (raltegravir) is both the first in its class and the only integrase inhibitor to be approved for very young children, MPP says. Moreover, it lacks some of the negative aspects of other HIV therapies for very young children, such as bad taste, high alcohol content and the need for refrigeration, United Nations-backed organization adds.

Both formulations are meant to be used in combination with other HIV therapies and are available in the U.S. and European Union for children as young as 4 weeks old who weigh at least 6.6 pounds.

Approximately 3.2 million children are thought to be living with HIV around the world, 98 percent of them in the targeted countries. Less than a quarter of these children are currently receiving antiretroviral treatment, according to Merck.

Read the agreement at www.fdanews.com/02-24-15-Merckagreement.pdf. — Lena Freund