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Grifols Receives Approval for New Medicine

07/12/2019

Grifols Receives FDA Approval for Xembify

Exciting news from Grifols here in Clayton! The company just got approved by the U.S. Food and Drug Administration for a medicine called Xembify. It will help to treats kids as young as 2 years old and adults who are suffering from immune deficiencies. It's estimated that about one child out of every 2,000 is diagnosed with rare and chronic disorders where their immune system can't quite fight off infections (the disorders are called PI or Primary Humoral Immunodeficiency.)  

Grifols plans to launch Xembify in the United States later this year and it will be something these kids and patients can inject under their skin to help Their bodies defend against infections! 

“We are pleased to offer patients living with this challenging chronic disease another important treatment option," a says Joel Abelson, president of Grifol's commercial bioscience division.

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.

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