New Drug Applications: adding value to existing compounds
Drugs can sometimes be developed to target a particular disease, but then further down the line, they can be used to treat other conditions, due to the overlapping pathways that the drug was designed to target – this is called New Drug Application (NDA). It is a good way to add value to existing products, and makes use of the extensive research done in developing it for safe use for its first indication. This conversion of use is quite common, but is none-the-less subject to strict FDA approval processes.
Sanofi have received approval for a NDA review of the drug Aubagio (teriflunomide) for relapsing forms of MS. A similar process with the European Medicines Agency (EMA) is expected during 2012. Other recent NDA filings include Kyowo Hakko Kirin’s Mogamulizumab (Poteligeo) for leukemia, and Pfizer’s bosutinib for CML.
With the orphan drugs initiatives, it is likely that we will be seeing more NDA reviews. It is an efficient use of existing compounds for the pharma companies, and is generating some effective treatments for difficult diseases