An Overview of Novel Drugs and New Chemical Entities in 2013

Abstract

Twenty-seven (27) new drugs have been approved by the U.S. FDA in 2013, a big decline compared to 39 in 2012. The decline is attributed to fewer drugs submitted for review. The average annual approval rate over the past eight years is 26 new molecular entities (NMEs) comprising small molecules and biologics. The approval of 27 novel new drugs is a strong sign of innovation in drug discovery and commercialization. This list includes 9 first-in-class drugs, 9 orphan drugs, 10 fast track drugs, 10 priority drugs, 3 breakthroughs, 2 accelerated aprovals and 12 combined expedited approval products. Many first-of-a-kind drugs have been approved for marketing. The list includes a total of 89% (24 of 27) first cycle approvals and 74% (20 of 27) first approvals in the U.S. before any other country. Noteworthy first-in-class drugs include canagliflozin (diabetes), ado-trastuzumab emtansine (late-stage breast cancer), simeprevir  (chronic hepatitis C), and trametinib (metastic melanoma). Among the breakthrough drugs approved in 2013 were ibrutinib (blood cancer), obinutuzumab (leukemia), and simeprevir  (chronic hepatitis C). In addition,  nine (33%) products were approved for the treatment of rare diseases including Imbruvica (mantle cell lymphoma), Gazyva (lymphocytic leukemia), Kynamro (familial hypercholesterolemia), and Adempas and Opsumit (pulmonary hypertention). The approval of 27 drugs in 2013 underscores a strong success rate, indicating innovations for new products despite the uncertain concerns about the long-term safety of NMEs in the existing climate of withdrawals and safety alerts. Despite encouraging drug approvals, there is a bleak scope for blockbusters because most of these drugs are for niche areas or have a limited market. The pipeline for 2014 appears very optimistic. Overall, these new drug additions to the current drug armamentarium are expected to contribute to improved health and will exert a great potential impact on public health.