Medicins Sans Frontieres this week called on Abbott Laboratories to speed up the registration of its heat-stable formulation of the protease inhibitor Kaletra, which the advocacy organisation says is urgently required for second-line treatment in developing countries. It also called on the company to offer the new formulation at the same price as the old formulation to low income countries.
Abbott says that it is waiting for European Union approval before it can register the new formulation in countries eligible for Abbott’s access programme, which offers the drug at a steeply discounted price in 69 least developed countries. The company claims that it requires European Union approval before many African countries will process local approval. In South Africa Abbott expects to file for registration within weeks, and says that it has been promised `expedited review` by the Ministry of Health.
MSF says that access to the heat-stable formulation of Kaletra is urgent because it is the only ritonavir-boosted protease inhibitor that is practical for use in hot climates. Abbott developed the new formulation in order to reduce the pill burden from three capsules to two pills twice daily, and to improve the stability of the drug, since research shows that at temperatures above 40 degrees centigrade Kaletra gel capsules beginning to lose their rigidity and drug content begins to decline within days.
The new pill version of Kaletra does not need to be refrigerated. Abbott is also working on a heat stable version of ritonavir, the protease inhibitor that can be used at a low dose in order to boost levels of all other protease inhibitors apart from nelfinavir.