A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
Dyax’s DX-2930, an experimental treatment for hereditary angioedema, has won FDA orphan drug designation. The human monoclonal antibody is designed to inhibit plasma kallikrein to reduce swelling, pain and inflammation associated with the disease, the drugmaker says.
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 9–6 Thursday to recommend approval of Genzyme and Isis Pharmaceuticals’ homozygous familial hypercholesterolemia (HoFH) drug Kynamro. The vote comes one day after the panel recommended approval of Aegerion’s HoFH treatment by a wider margin. As with Aegerion’s lomitapide, EMDAC panelists expressed numerous concerns over Kynamro’s (mipomersen) safety profile. Drug Industry Daily