In 2014, the FDA’s Center for Drug Evaluation and Research (CDER) approved a record 41 new medicines, making it a particularly strong year of innovation for America’s biopharmaceutical companies. This continues a trend in recent years towards a higher annual number of new medicines.
While the quantity of new medicines is a significant achievement, even more notable is the role they will play in helping patients to live longer, healthier lives. Of the approved medicines, nearly 41 percent were first in class treatments, meaning that they use a completely new approach to fighting a disease, and more than 20 percent were personalized medicines. Among the new medicines are innovative cancer treatments with the potential to prolong and transform patients’ lives, therapies for hepatitis C with cure rates of more than 90 percent, and a record-setting 17 medicines to treat rare diseases.
Last year’s remarkable number of approvals is in part due to the industry’s efforts to pursue new, collaborative approaches to streamline the research and development process. And while it’s clear progress has been made, the road to bringing a new FDA-approved medicine remains long and formidable. On average, it takes 10 to 15 years and more than $2.6 billion to bring a new medicine from the research pipeline to patients. And only 12 percent of drug candidates that enter clinical testing are eventually approved for use by patients.
While R&D remains a challenge, the number of new medicines approved in 2014 is illustrative of our industry’s commitment to patients. In 2015 and beyond, America’s biopharmaceutical companies will continue to research new treatments to improve lives and give patients even greater hope for the future.