Drug Development Investments Riskier for Diabetes Medications

Only 12.8% of all experimental diabetes drugs transition to phase 3 trials.

A recent study found that developing new drugs for diabetes may be riskier compared with developing drugs for any other disease.

Diabetes and non-endocrine drugs have been found to have a much lower rate for receiving approval, making drug development potentially much riskier for pharmaceutical companies. Due to increased risks of obesity, heart disease, and other associated diseases, controlling diabetes is critical for beneficial patient outcomes.

Included in a study conducted by the Tufts Center for the Study of Drug Development, were information about development pathways and characteristics for 27 diabetes drugs and 34 non-diabetes endocrine drugs. These drugs accounted for only 10% of FDA-approved drugs between 1995 to 2015.

Researchers discovered that only 1 of 13 experimental diabetes drugs tested between 1995 and 2007 received FDA approval. The average approval rate for all investigational drugs was 1 in 8 during this time, according to the study.

Experimental diabetes drugs are less likely to enter phase 3 clinical trials than all experimental drugs. Only 12.8% of experimental diabetes drugs would advance, while 21.1% of all drugs would enter phase 3 studies.

However, those that do enter phase 3 trials have a slightly higher approval rate than all drugs, according to Tufts University. Researchers found that 60% of diabetes drugs received approval, and 56% of all drugs received approval.

Approximately 15% of approved diabetes drugs from 1995 to 2015 received priority review designation. Researchers found that 50% of non-diabetes endocrine drugs, and 46% of all non-endocrine drugs that were approved during this time also received this designation.

“Creating new drugs to treat diabetes poses special development challenges, as reflected in part by Food and Drug Administration regulatory guidelines promulgated in 2008 that require developers to demonstrate cardiovascular safety in large trials that include high-risk patients," said lead researcher Joseph A. DiMasi. “Diabetes is a major cause of morbidity and mortality, and its incidence in the US, according to the Centers for Disease Control and Prevention, has tripled since 1980. Although there are numerous hypoglycemic agents on the market, there remains a strong need for new drugs that will reduce the human suffering and economic costs associated with this highly prevalent disease.”