Neglected disease approvals up 2013
The annual number of new drug approvals globally to treat neglected diseases has nearly doubled in recent years, with HIV/AIDS and malaria drugs accounting for 60 percent of the most recent approvals, according to research by The Tufts Center for the Study of Drug Development. During an eight year period from 2000 to 2008, an average of 2.6 new drug products, including new molecular entities, vaccines, indications, combinations, and formulations, were approved each year to combat neglected diseases. The number increased to an average of five per year in 2009 to 2012, according to Tufts CSDD.
The analysis, reported in the July/August Tufts CSDD Impact Report, is the latest in a continuous series of studies that track progress in drug development targeting neglected diseases, in addition to patient access to existing products through donation programs.
“We are observing growth in drug development – the annual number of approvals has doubled when we compare the period 2009-2012 to 2000-2008 – but only 25 percent of new approvals are new molecular entities or new vaccines,” says Joshua Cohen, Ph.D., assistant professor at Tufts CSDD, who served as principal investigator on the study. “Approximately 60 percent of new approvals target ‘Big Three’ neglected diseases – malaria, TB, and pediatric indications for HIV. Several diseases, such as Buruli ulcer, Dengue fever, and trachoma, have not seen any new approvals. There are products in development (the number is 16 in Phase III), but again the ‘Big Three’ dominate, while few drugs in Phase III are targeting lesser-known neglected diseases.”
Neglected diseases are typically tropical infections most commonly found in developing countries where the population lacks the income to pay for drug treatments. This lack of purchasing power has dissuaded some drug developers from investing in therapeutics to treat these indications.
“It is important to note that new approvals are a necessary but insufficient condition to improved patient access to pharmaceuticals targeting neglected diseases,” Dr. Cohen told Med Ad News. “Patients in developing nations often cannot afford new branded products or even older generics. Therefore, they rely on access mechanisms, such as patient assistance programs, which provide free or subsidized pharmaceuticals. We have seen growth in such programs in recent years, and a commitment from pharmaceutical companies to eradicate certain neglected diseases with continued free donations of products targeting neglected diseases, such as leishmaniasis and leprosy.”
Although increased approvals may lead to greater access to new medicines, Dr. Cohen believes that policy makers need to ensure that healthcare systems adopt safe, effective, and easy to administer products that are also affordable and accessible to patients. “The important take-home message is that all relevant stakeholders, from the pharmaceutical industry, to product development partnerships, to philanthropic donors must work together to increase the supply of donated or subsidized medicines, and improve the delivery mechanisms to ensure that drugs make it into the hands of those who need them most,” he says.