Last week, John Jenkins, M.D. issued a review of the FDA’s new drugs program in the Center for Drug Evaluation and Research (CDER). The total number of new drug approvals decreased dramatically in 2016 versus the previous year; however, Jenkins, who is the Director of the Office of New Drugs in FDA’s CDER, approaches the numbers with optimism (fda.gov). Twenty-two novel drugs received approval by CDER, and most of these drugs could add “significant clinical value” to the care of thousands of patients with serious and life-threatening illnesses.
2016 could be viewed as a year of “firsts” for new drug approvals. Spinal muscular atrophy and Duchenne muscular dystrophy both received first treatments. Parkinson’s disease related hallucinations and delusions, primary biliary cirrhosis, and hepatitis C each received new treatments. Several new oncology drugs obtained approval to help patients with ovarian cancer, bladder cancer, soft tissue sarcoma, and chronic lymphotic leukemia. CDER approved two new diagnostic agents used to detect certain forms of cancer as well. Jenkins notes that 73% of the 22 novel products benefited from at least one of the FDA’s programs to expedite new drug development and review. Another promising statistic from the CDER review team is that 95% of the novel drug products they reviewed last year were “first cycle” products. This means that CDER did not need to request additional information from submitters to approve the product. Find an extensive look at all of last year’s new drug approvals in the FDA’s 2016 Novel Drugs summary.
The high usage rate of an FDA fast-track program indicates efficiency within the approval process. The nearly 100% “first cycle” approvals suggests that life science companies are submitting accurate and comprehensive clinical trial data. Pearl Pathways prides itself on helping companies and researchers successfully expedite the product development life cycle. Last year alone, our team provided expert insight into the FDA’s Fast Track, Breakthrough Therapy, and priority review designations to several of our clients. Please contact us today to find out how we can help you with your new treatments in 2017 and beyond.