Pharming to receive negative opinion for angioedema drug

Pharming understands that the Committee for Medicinal Products for Human Use (CHMP) does not have a specific concern on the safety and efficacy data submitted in the marketing authorization application (MAA) and have accepted all the non-clinical and quality aspects of the product. However, the committee is not reassured about the potential for undesirable immune responses following repeated administration.

Based on this development, the company intends to re-submit the registration dossier with the inclusion of additional clinical data from the recently completed North American clinical study when these results become available in the second quarter of 2008. As part of the re-submisson, Pharming will request an expedited review which is an assessment period of 150 days. In the meantime the company will pursue registration in markets outside the EU.

Francis Pinto, CEO of Pharming, said: “We remain committed to making Rhucin available to European HAE patients by refiling our MAA with additional data and obtaining approval under an expedited review from EMEA.”