Grifols, S.A. (NASDAQ:GRFS) reported the Food and Drug Administration's approval of Xembify, its new 20% subcutaneous immunoglobulin for treating primary immunodeficiencies.
The company, based in Barcelona, is a leading global producer of plasma-derived medicines
The FDA nod marks the culmination of an important R+D+i initiative for Grifols, as well as an opportunity to enhance the Bioscience Division's product portfolio.
Grifols is currently a market leader in the production and marketing of immunoglobulins, with 30.3% market share (grams) in the United States. Thus, this approval reinforces Grifols' commitment to patients in the United States, allocating an increasing part of its production to supply the needs of this market.
According to one company official, "This approval reinforces Grifols' longstanding commitment to patients and health-care professionals by expanding our product portfolio to better serve individuals with primary immunodeficiencies. We are pleased to offer patients living with this challenging chronic disease another important treatment option."
The company plans to launch Xembify® in the United States in the last quarter of 2019 and is working with healthcare authorities to obtain approval in Canada, Europe and other markets.
Grifols intends to allocate EUR 1,400 million toward capital investments over 2018 through 2022 in order to meet the growing demand for plasma-derived medicines and reinforce its long-term growth plan.
Shares in Grifols opened upwards 44 cents, or 2.1%, to $21.84
