Regulatory agencies offer marketing approval for new products to treat neglected diseases

New products to treat neglected diseases have received marketing approval from regulatory agencies at a steadily increasing rate in recent years as R&D funding for those diseases has increased, according to a recently completed study by the Tufts Center for the Study of Drug Development.

According to the study, the annual rate of new product approvals worldwide for neglected diseases increased from an average of 1.8 in 1975-99 to 2.6 in 2000-09.

Neglected diseases include malaria, kinetoplastids, diarrheal diseases, helminths (e.g., roundworm), bacterial pneumonia and meningitis, and typhoid and paratyphoid fever.

"During this past decade, a significant increase in R&D funding for neglected diseases has led to marketing approval for 26 drugs and vaccines," said Joshua Cohen, senior research fellow at Tufts CSDD Director of Economic Analysis and author of the study.

He added, "While increased approvals are necessary to improve access, policymakers need to ensure that safe, effective, and easy-to-administer products are adopted by health care systems and providers on a consistent basis, that they are affordable, and that they reach the people who need them."

The Tufts CSDD analysis examined the results of a widely circulated 2002 study, which reported that only 16 of 1393 new chemical entities marketed between 1975 and 1999 targeted tropical diseases and tuberculosis. Tufts CSDD found that the more accurate count was 33. However, the earlier study prompted governments, nonprofit foundations, and private-public partnerships to increase funding for neglected diseases, from less than $100 million annually a decade ago to more than $2.5 billion annually today.

The new analysis, reported in the November/December Tufts CSDD Impact Report, released today, also found that:

* Drugs to treat HIV/AIDS and malaria accounted for 81% of approvals during 2000-09.

* Vaccines have displaced drugs as the main products being developed for neglected diseases, accounting for 76% of all products in development to treat neglected diseases.

* Public-private partnerships accounted for 46% of all new product development to treat neglected diseased during 2000-09, up from 15% in the 1975-99 period.