CSL Ltd.'s autoimmune disorder medicine has been granted orphan drug designation by the U.S. Food and Drug Administration.
The regulator's decision on CSL's Hizentra provides for a seven-year period of marketing exclusivity in the U.S. as a maintenance therapy to prevent the return of chronic inflammatory demyelinating polyneuropathy in certain adult patients. The disorder targets the peripheral nerves and may cause permanent nerve damage.
The FDA grants the designation for medications that treat rare diseases affecting fewer than 200,000 patients in the U.S.
Hizentra is already approved in Japan and the U.S. to prevent relapse of chronic inflammatory demyelinating polyneuropathy in adults. Additionally, the drug is approved in over 50 countries to treat certain immune deficiencies.