Over the past decade, neglected diseases have attracted increased attention and larger investments in research. Even often overlooked tropical diseases such as sleeping sickness and leishmaniasis have received more funding. “These Cinderella diseases, long ignored and underappreciated, are a rags-to-riches story,” said Margaret Chan, director-general of the World Health Organization, in an address in May. But these newfound ‘riches’ have given rise to just a few dozen newly approved therapies and only a handful of truly novel drugs. A new analysis by Médecins Sans Frontières (MSF) and the Drugs for Neglected Diseases Initiative (DNDi) finds that the rate of approvals for new compounds over the past decade is roughly the same as it was during the previous two-and-a-half decades, when the diseases received little attention.
“It is still a very depressing picture,” says Manica Balasegaram, head of MSF’s Access Campaign in Geneva. “This is a little bit disheartening considering the huge amount of activity that’s been happening in the global health world.”
The new analysis, presented today at a symposium in New York, shows that of the 850 new therapies and vaccines approved by the US Food and Drug Administration, the European Medicines Agency and other agencies between 2000 and 2011, 37 focused on neglected diseases, and just four of those were new chemical entities. The work builds on a pioneering paper published in 2002 by members of the Drugs for Neglected Diseases Working Group, which counted 1,393 new drug approvals—16 of which focused on neglected diseases—between 1975 and 1999 (Lancet 359, 2188–2194, 2002). According to DNDi, 11 of those 16 drugs could be considered new chemical entities. The numbers suggest that although the rate of approvals for drugs for neglected diseases has gone up, the rate of approvals for new chemical entities seems to have remained relatively flat.
Direct comparisons, however, are difficult, as the new analysis is more comprehensive than the previous one, and tallying drug approvals can prove challenging. Joshua Cohen, a health economist with the Tufts Center for the Study of Drug Development in Boston, reanalyzed the working group’s data a few years ago and came up with a different count—32 new drugs approved for neglected diseases, including 13 new chemical entities (PLoS ONE 5, e10610, 2010).