Aegerion Pharmaceuticals Inc (fka AEGR)

[surf1944]

9:22AM Aegerion Pharma comments on standard review classification for Lomitapide NDA, 'we are comfortable with the justification' (AEGR) 13.86 : The FDA provided a clear and executable pathway for Aegerion to file an NDA based upon 56-week data from a single, open label, 78-week Phase III clinical trial in 29 patients with HoFH, with a primary endpoint of LDL-C reduction. In light of this surrogate endpoint, the NDA has been given a standard review classification as it is not feasible to study cardiovascular outcomes in the HoFH patient population. Co plans to initiate a clinical study of lomitapide for the treatment of FC in 2012.