Delivering Dosing Options for Patients With a Rare Neurological Disease
From conditions affecting millions of people to rare disorders impacting just a few, we are committed to supporting a range of treatment solutions that make a difference in the lives of the patients we serve. The February 2021 U.S. Food and Drug Administration (FDA) approval of Panzyga® (Immune Globulin Intravenous [Human] – ifas 10 percent Liquid Preparation) as a treatment for adults with a neurological disease of the peripheral nerves called chronic inflammatory demyelinating polyneuropathy (CIDP) is one example of how we’re helping to transform the care of patients living with rare diseases.1
“Each patient with CIDP has different treatment needs, and we have found that having one approved dosing option is not always optimal,” said Angela Lukin, Global President, Hospital Therapeutic Area at Pfizer. “The approval of this new indication with additional dosing options helps address an unmet patient need by providing healthcare providers with the ability to choose an approved dose that’s right for patients.”
CIDP is a rare disorder of the peripheral nerves characterized by gradually increasing symmetrical motor and sensory loss and weakness associated with loss of deep tendon reflexes. The number of new cases of CIDP each year is about one-two per 100,000 people.2 Given the debilitating nature of CIDP, the approval of Panzyga with dosing options enables physicians to address specific patient needs.
Most individuals with CIDP will require long-term treatment and, if left untreated, about one-third will eventually require the use of a wheelchair.3 Early recognition and proper treatment are critical in helping patients avoid significant disability, and we are proud of our role in meeting the different treatment needs of these patients and fundamentally transforming what it means for them to live with a rare disease.
This is the third indication for Panzyga, which was approved by the FDA in 2018 for the treatment of primary immunodeficiency in patients two years of age and older and chronic immune thrombocytopenia in adults. Our continued investment in supporting this important therapy reflects our ongoing dedication to advancing science across a spectrum of diseases.
Pfizer Inc. and Octapharma AG are parties to a license agreement pursuant to which Pfizer is granted rights to market and commercialize Panzyga in the U.S. Octapharma manages all clinical programs and regulatory filings and retains exclusive rights to commercialize this product globally outside of the U.S.
Please see full prescribing Information, including BOXED WARNING for Panzyga available at http://labeling.pfizer.com/ShowLabeling.aspx?id=12355.
GBS/CIDP Foundation International. What is Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)?. https://www.gbs-cidp.org/cidp/?utm_source=google&utm_medium=cpc&gclid=CjwKCAiAs92MBhAXEiwAXTi25zZiFuHlGdEFRRg3Rctumodjh3QqT5AIm6nGLVCsoSMylX_v13AYkhoCXrAQAvD_BwE. Accessed November 19, 2021.
Johns Hopkins Medicine. Chronic Inflammatory Demyelinating Polyradiculoneuropathy. https://www.hopkinsmedicine.org/health/conditions-and-diseases/chronic-inflammatory-demyelinating-polyradiculoneuropathy. Accessed December 3, 2021.