Grifols Receives FDA Approval for Xembify
Grifols’ product portfolio just got a little larger with U.S. Food and Drug Administration approval of Xembify, a treatment for immune deficiency.
The medicine, a 20% immunoglobulin solution for subcutaneous -- or beneath the skin -- injection, treats Primary Humoral Immunodeficiency (PI) in patients 2 years old and older.
PI comprises more than 350 rare and chronic disorders caused by a compromised immune system that lacks the defenses to fight off infections. While the exact prevalence of the disease is unknown, estimates are that about one child out of every 2,000 is diagnosed with some form of PI.
Grifols plans to launch Xembify in the United States in the fourth quarter of this year. The company also is laying the groundwork to sell the product in Canada, Europe and other global markets.
“This (U.S.) approval reinforces Grifols’ longstanding commitment to patients and healthcare professionals by expanding our product portfolio to better serve individuals with primary immunodeficiencies,” said Joel Abelson, president of the company’s commercial bioscience division. “We are pleased to offer patients living with this challenging chronic disease another important treatment option.”
Grifols -- a leading global producer of plasma-derived medicines that is headquartered in Spain -- has a major presence in Clayton. The company currently is investing close to $200 million at its manufacturing site there to build the world’s first purification, sterile filling and flexible packaging facility to produce immunoglobulin and factor VIII products. Immunoglobulin is a therapy for various autoimmune, infectious and other diseases. Factor VIII -- a blood protein involved in clotting -- treats the bleeding disorder hemophilia A.
The new facility, scheduled to open in 2022, will support the site’s $400 million plasma-fractionation plant that began operations in 2014. Grifols has invested close to $1 billion in its North Carolina operations since coming to the state in 2011. The company has announced plans to invest close to $2 billion globally between 2018 and 2022 to meet the growing demand for plasma-derived medicines.
The FDA’s favorable decision on Xembify follows close on the heels of its 2018 approvals of Grifols’ GamaSTAN -- an intramuscular immunoglobulin that provides immediate protection against hepatitis A and measles -- and HyperRAb, an anti-rabies treatment. The company is a leader in manufacturing immunoglobulin products for patients in the U.S., with more than a 30 per cent share of the market.