Cytomegalovirus immunoglobulin

9778000

New Medicines

Cytotect CP Biotest · Cytomegalovirus (CMV) infections - prevention in patients subjected to immunosuppressive therapy, particularly in transplant recipients

Information

Cytotect CP Biotest
New molecular entity
Biotest
Not Known

Development and Regulatory status

Launched
Launched
None
January 2020
Jan 20 · Available in the UK. Packsize 1x10ml(1000 U anti-CMV antibody) and 1x50ml (5000 U anti-CMV antibody) pricing being discussed with the Department of Health [6].
Jan 20 · Cytomegalovirus immunoglobulin has been available in selected European countries (Austria, Belgium, Germany, Greece, Hungary, Italy, Netherlands, Portugal) under the brand names Cytotect CP and Megalotect CP [2,3].
Jan 20 · Approved by the MHRA for prophylaxis of clinical manifestations of cytomegalovirus infection in patients subjected to immunosuppressive therapy, particularly in transplant recipients [1].

Category

An immunoglobulin preparation from plasma of donors with a high antibody titer against the CMV. It has a defined and high titer of high avidity anti-CMV antibodies. It also contains IgG antibodies against other pathogens.
In 2015/16, 1,364 people became organ donors when they died and their donations resulted in 3,519 transplants taking place [4]. CMV infection is a frequent complication after transplantation, occurring mainly 30 to 90 days after transplantation. The major risk factors are when the recipient is CMV seronegative and the donor is seropositive, as well as when lymphocyte-depleting antibodies are used [5].
Cytomegalovirus (CMV) infections - prevention in patients subjected to immunosuppressive therapy, particularly in transplant recipients
Intravenous infusion

Trial or other data

Jan 20 · The clinical efficacy of CMVIG has been investigated in different settings, including patients who received solid organ and stem cell transplants. In renal transplantation, CMVIG reduced the incidence of CMV infection from 41.7% (control group) to 21.1% (Cytotect group). Other examples include lung transplantation, where the incidence of CMV disease was reduced from 43.3% (control group) to 13.2% (Cytotect group), and bone marrow transplantation, where the incidence of interstitial pneumonitis was reduced from 26.1% to 3.8% [1].