Analysis reflects a near doubling of annual new drug approvals for neglected diseases
By Mia Burns
The Tufts Center for the Study of Drug Development has released new analysis indicating that 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. 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 (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, PhD, 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. The 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 leishmaniasisand leprosy.”
Although increased approvals may lead to greater access to new medicines, according to Dr. Cohen, 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 told Med Ad News.
Number of Annual New Drug Approvals to Treat Neglected Diseases Has Nearly Doubled Between the Early-2000s and 2009-12, According to the Tufts Center for the Study of Drug Development
The Tufts Center for the Study of Drug Development has released new analysis indicating that 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. 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 (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, PhD, 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. The 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 leishmaniasisand leprosy.”
Although increased approvals may lead to greater access to new medicines, according to Dr. Cohen, 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 told Med Ad News.
Number of Annual New Drug Approvals to Treat Neglected Diseases Has Nearly Doubled Between the Early-2000s and 2009-12, According to the Tufts Center for the Study of Drug Development
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