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 has approved Eisai’s Fycompa tablets to treat partial-onset seizures in epilepsy patients ages 12 and older. Partial seizures are the most common type of epileptic seizure and some patients do not get satisfactory control from current treatments, Russell Katz, director of CDER’s Division of Neurology Products, said Monday. “It is important to have a variety of treatment options available for patients with epilepsy.” Drug Industry Daily