South Africa's Aspen Wins PEPFAR Approval From US FDA

Leading South African generics maker Aspen Pharmacare has received tentative approval for a combination antiretroviral under the US government's PEPFAR initiative. The approval, which does not apply to the US, is a significant move for the US$15bn programme's accelerated US FDA review process.

Although the US FDA approved Barr Laboratories' HIV/AIDS generic under the initiative last month, Aspen's drug could reach a wider market, and the approval is the first of its kind for a foreign drug company. The product combines three medicines, two of which are manufactured as Combivir (lamivudine and zidovudine) by UK-based drug major GlaxoSmithKline, while the other is produced by Germany's Boehringer Ingelheim as Viramune (nevirapine). Generic versions of Viramune are already widely distributed in Sub-Saharan Africa, although the drug has been the subject of recent controversy relating to the authenticity of its clinical trials data.

HIV/AIDS campaign groups have largely welcomed the approval, as the product is likely to cost up to a third less than some existing antiretroviral medicines. Meanwhile, with roughly 60% of the PEPFAR initiative's funding earmarked for purchases of drugs from approved suppliers, Aspen's market valuation has already substantially increased. Nevertheless, rival generics producers are not far behind, with Indian generics major Ranbaxy recently announcing that it has filed three antiretrovirals under the PEPFAR review process.