Novel drugs are new therapeutic options that expand our healthcare system to treat more diseases and address unmet public health needs. These newly synthesized drugs are also referred to as New Molecular Entities or NMEs. They contain active moieties that have not yet been identified or approved by the FDA. The terms, “active moieties,” refer to the part of a molecule or ion that is responsible for the physiological or pharmacological action of the drug.
Although an NME and a “new chemical entity” or NCE sound similar in their designation titles, they are different. Unlike NMEs, NCEs refer to drugs that do not contain active moieties that have been approved by FDA in any other NDA. In other words, these drugs do not have a single approved moiety that is active. Generally, an NCE is a molecule created in the early stages of drug development that could translate into a useful drug, while an NME is a compound of molecules that is discovered during drug development.