Pharming has confirmed its interactions in a pre-BLA meeting with the FDA on a proposed marketing application (BLA or Biologics License Application) to obtain marketing approval for Rhucin for the treatment of acute attacks of HAE (hereditary angioedema).
In a pre-BLA meeting, FDA and the sponsor can discuss the outline of the application in advance of submission to avoid potential pitfalls in the review process. The results of these meetings are confidential. Based on the outcome, Pharming will determine its next steps on the path to market approval and will update the market on the process as soon as public information becomes available.
In the US, biological products are approved for marketing under the provisions of the Public Health Service (PHS) Act. The Act requires a firm which manufactures a biologic for sale in interstate commerce to hold a license for the product. To commercialise the new biological product in the US, the FDA needs to approve a Biologics License Application (BLA).
A BLA is a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product. If the information provided meets FDA requirements, the application is approved and a license is issued allowing the company to market the product.