Posted from: Monday, October 09, 2017 - 06:05 PM - Present

Privigen Approved for CIDP

September 14, 2017 – The U.S. FDA has approved Privigen® [Immune Globulin Intravenous (Human), 10% Liquid], manufactured by CSL Behring, for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP), to improve neuromuscular disability. CIDP is a progressive neurological disorder that affects approximately 40,000 patients in the United States; it causes motor and sensory impairment in both sides of the body, particularly in the arms and legs. Patients with CIDP often experience weakness, numbness, and tingling in their arms and legs as a result of damaged myelin sheaths, which act as protective coverings for peripheral nerves.

Privigen was originally approved in 2007 to treat primary humoral immunodeficiency (PI) and chronic immune thrombocytopenic purpura (ITP) in patients 15 years of age and older. The drug is available as an intravenous infusion; dosing is based on indication and the patient’s weight. Privigen carries a black box warning for risk of thrombosis, renal dysfunction, acute renal failure, osmotic nephropathy, and death.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

 

Last Updated Monday, September 24, 2018 - 03:38 AM.