Akcea Therapeutics, Inc. an affiliate of Ionis Pharmaceuticals, Inc., and Ionis Pharmaceuticals, Inc., received a Complete Response Letter (CRL) from the Division of Metabolism and Endocrinology Products of the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Waylivra (volanesorsen). “We are extremely disappointed with the FDA’s decision. FCS is an ultra-rare and debilitating…
Study Results Show Multiple Benefits Of Patient-To-Patient Connectivity In FCS
Akcea Therapeutics, Inc., an affiliate of Ionis Pharmaceuticals, Inc., focused on developing and commercializing drugs to treat people with serious and rare diseases, announced the publication of results from the first-ever study demonstrating the benefits of patient-to-patient connectivity in the management of familial chylomicronemia syndrome (FCS). FCS is a rare, potentially life-threatening disease with multiple severe,…