Novel drugs and new chemical entities in 2013 Academic Article uri icon

abstract

  • 2015, Indian Pharmaceutical Association. All rights reserved. Twenty seven 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. 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. 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 hypertension). Despite such 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 armamentorium are expected to contribute to improved health and will exert a great potential impact on public health.

published proceedings

  • Pharma Times

author list (cited authors)

  • Reddy, D. S.

complete list of authors

  • Reddy, DS

publication date

  • January 2014