Biotest AG: Biotest's CMV-specific hyperimmunoglobulin Cytotect CP Biotest receives UK marketing authorisation
News: Biotest AG / Key word(s): Regulatory Approval
Biotest's CMV-specific hyperimmunoglobulin Cytotect CP Biotest receives UK marketing authorisation
"We are pleased that approval has been granted for Cytotect CP Biotest in the UK. Cytomegalovirus is one of the most common opportunistic pathogens after solid organ and stem cell transplantation. The availability of Cytotect CP Biotest will provide transplant physicians with additional strategies to prevent and manage CMV infection and thereby improve patient care and post-transplant recovery", says Patricia Morey, Managing Director, Biotest UK.
In the UK, annually more than 3,700 patients receive a kidney, lung, heart or liver transplant, while almost 1,700 patients undergo allogeneic hematopoietic stem cell transplantation. Infection with CMV can occur in up to one third of these patients and, if left untreated, can cause serious complications leading to organ rejection, graft-versus-host disease (GvHD) as well as tissue-invasive disease (e.g. colitis, pneumonitis or retinitis).
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. Cytotect CP Biotest is indicated for prophylaxis of clinical manifestations of CMV infections in patients subjected to immunosuppressive therapy, particularly in transplant recipients, and is recommended as concomitant therapy alongside virostatic agents. Cytotect CP Biotest has a specific and targeted unique mode of action, which is different, yet complementary to antivirals.
Cytotect CP Biotest is an important contributor to Biotest's future business, is sold in more than 30 countries, and has seen a double-digit sales increase in 2019.
Now that Cytotect CP Biotest has been approved, patients throughout the UK can benefit from an additional therapy option to prevent the clinical manifestations of CMV infection.
About Cytotect CP Biotest(R)
Ordinary shares: securities' ID No. 522720; ISIN DE0005227201
 NHS Blood and Transplant, Organ Donation and Transplantation Directorate, https://www.organdonation.nhs.uk/
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