CPMP's Position On Assessing Anti-HIV Drugs

The European Commission Comm-ittee on Medicinal Products has released a document, Points to Consider in the Assessment of Anti-HIV medicinal Products. Although it is mainly intended for internal use by the CPMP and European Union member states, the CPMP notes that its view that a new drug approval must be based on data showing clinical benefits relevant to patients has implications for companies working in this area. The Committee will update the document in accordance with progress and the changing conditions for conducting clinical trials.

1: The document's objective is to define the minimim efficacy criteria for unconditional licensing of a new anti-HIV medicinal product, and to propose the prerequisites necessary for granting a marketing authorization under exceptional circumstances, in accordance with Council Regulation (EEC) No 2309/93.

2: Definitions and Validity of Endpoints. 2.1: Survival is the gold standard in an ultimately fatal disease, and a justifiable and necessary endpoint in long-term clinical trials. It will not normally be reached in trials evaluating short-term efficacy.