Washington, DC ― The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research’s (CDER) fifth annual Novel New Drugs Summary reported that 45 new medicines were approved in 2015.
Thirty-six (36) percent of the new FDA-approved medicines were "first-in-class" treatment options — offering a new way to treat diseases — and 47 percent were for rare diseases.
Thirty-six (36) percent of the new FDA-approved medicines were "first-in-class" treatment options — offering a new way to treat diseases — and 47 percent were for rare diseases.
Among the new drugs are:
According to the Pharmaceutical Research and Manufacturers of America (PhRMA), last year’s remarkable number of FDA approvals is in part due to the biopharmaceutical industry’s efforts to pursue new, collaborative approaches to streamline the research and development process.
- Novel oncolytic virus therapy for the treatment of melanoma, which is the most common cancer type in the United States.
- A new generation of cancer treatments, including immunotherapies and personalized medicines
- New treatments for diabetes, asthma and irritable bowel syndrome
- A new class of cholesterol-lowering medicines that address a significant unmet medical need for patients who couldn’t be treated with statin therapies.
According to the Pharmaceutical Research and Manufacturers of America (PhRMA), last year’s remarkable number of FDA approvals is in part due to the biopharmaceutical industry’s efforts to pursue new, collaborative approaches to streamline the research and development process.
