Pfizer's PANZYGA Wins FDA Approval For Rare Peripheral Nerves Disorder - Pfizer (NYSE:PFE)

The FDA has approved Pfizer Inc's (NYSE: PFE) supplemental marketing application seeking approval for PANZYGA (immune globulin intravenous, human - ifas) for chronic inflammatory demyelinating polyneuropathy (CIDP), caused by damage to the covering of the nerves, called myelin, and is characterized by motor and sensory loss and weakness associated with loss of deep tendon reflexes.
According to the company, PANZYGA is the only intravenous immunoglobulin (IVIg) with two FDA-approved maintenance dosing options for CIDP. PANZYGA can also be administered at infusion rates up to 12 mg/kg/min.
The FDA already approved the drug for primary immunodeficiency (PI) in patients two years of age and older and for chronic immune thrombocytopenia in adults.
Pfizer has marketing and commercialization rights to PANZYGA in the U.S., while Octapharma retains exclusive rights outside of the U.S.
Price Action: PFE stock gained 0.55% at $34.91 in premarket trading on the last check Tuesday.