Biotest AG: Biotest’s Hyperimmunoglobulin Cytotect® CP receives five additional Marketing Authorisations in Europe
EQS-News: Biotest AG
/ Key word(s): Regulatory Approval
"We are pleased to receive additional marketing authorizations for Biotest’s hyperimmunoglobulin in these five European markets," said Enrico D’Aiuto, Senior Vice President, Head of Global Sales and Marketing. "Our commitment to improving patients' lives remains strong, and we will continue to work diligently to bring our treatments to transplant patients around the world."
Biotest’s hyperimmunoglobulin is a human cytomegalovirus immunoglobulin, which is used for the prophylaxis of clinical manifestations of CMV infections in patients who receive immunosuppressive therapy, particularly after they have undergone solid organ or stem cell transplantation. CMV infections can cause serious complications in those vulnerable patients who have received transplants, and Cytotect® CP Biotest is an important tool in reducing the risk of such infections. With these new marketing authorizations, even more vulnerable transplant patients can benefit from the protection provided by Biotest’s CMV-hyperimmunoglobulin.
The marketing authorizations for Biotest’s CMV-hyperimmunoglobulin were granted following a thorough review of clinical data including the well-characterised safety profile by the corresponding national authorities. Worldwide, Biotest is one of only two providers of this class of product, with Cytotect® CP Biotest being the only CMV-hyperimmunoglobulin available in Europe. Biotest AG is committed to ensuring the safety and efficacy of all its products, and the approval of Biotest’s CMV-hyperimmunoglobulin in these markets is a testament to the company's rigorous approach to drug development.
About Cytotect® CP Biotest
Cytotect® CP Biotest is a cytomegalovirus (CMV)-specific hyperimmunoglobulin preparation with a high antibody titre against CMV. The product is approved for prophylaxis of clinical manifestations of CMV infection in patients subjected to immunosuppressive therapy, particularly in transplant recipients. The concomitant use of adequate virostatic agents should be considered for CMV-prophylaxis. Cytotect® CP (also marketed in various countries as Megalotect®, Megalotect CP®, Cytomegatect®, Cytotect®, Cymvigo® and NeoCytotect®).
Biotest is a provider of plasma proteins and biological drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. Biotest has more than 2,300 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German stock exchange. Since May 2022, Biotest is part of the Grifols Group, Barcelona, Spain (www.grifols.com).
Dr Monika Buttkereit
Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com
Ordinary shares: securities’ ID No. 522720; ISIN DE0005227201
04.05.2023 CET/CEST Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group AG.
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