FDA, EMA approve CSL's Hizentra for CIDP

CSL Ltd. (ASX:CSL) subsidiary CSL Behring said FDA and the European Commission have each approved Hizentra human immune globulin as a maintenance treatment to prevent relapse of neuromuscular disability and impairment in patients with chronic inflammatory demyelinating polyneuropathy (CIDP), an autoimmune disorder that affects peripheral nerves.

The company said Hizentra is the first subcutaneous immunoglobulin formulation approved as a maintenance therapy for CIDP. It announced FDA's approval March 16 and the EU approval on March 15...