Janssen&Janssen schreef op 21 maart 2022 18:56:
Jongens blijf maar denken dat C1 inhibition alleen maar werkzaam is op HAE, waarom krijgt pharmings concurrent dan een update van de EMA voor een graft delay met hun C1 inhibitor
EU/3/18/2114: Orphan designation for the treatment in solid organ transplantation
Solid organ transplantation is a surgical procedure in which a diseased organ, such as the heart, lungs, liver or kidney, is replaced with an organ from a donor.
Transplantation is a very complex procedure. During transplantation, the organ to be transplanted can become damaged because of the interruption and restoration of blood supply to the organ. In addition, graft rejection can occur after transplantation when the patient's body rejects the transplanted organ. Graft rejection is caused by the patient's immune system (the body's natural defences) recognising the transplanted graft as 'foreign' and attacking it.
These complications can be debilitating and life-threatening because they may result in the transplanted organ not working properly.
At the time of designation, several medicines were authorised in the EU to treat graft rejection in solid organ transplantation. These include antibodies such as antilymphocyte immunoglobulin and thymoglobulin, medicines that suppress the immune process such as azathioprine, ciclosporin, mycophenolate mofetil and tacrolimus, and corticosteroids such as prednisolone or methylprednisolone.
The sponsor has provided sufficient information to show that the medicine might be of significant benefit for patients undergoing solid organ transplantation. Initial studies in patients with a kidney transplant suggest that adding the medicine to standard treatment to control rejection can improve the functioning of the transplanted organ. This assumption will need to be confirmed at the time of marketing authorisation, in order to maintain the orphan status.
C1 esterase inhibitor is a natural protein extracted from human blood that helps to control the action of various enzymes and processes, including the complement system. The complement system is made up of a group of proteins in the blood that help the immune system to work. The complement system plays a critical role in the development of graft rejection. Giving additional C1 esterase inhibitor to patients after solid organ transplantation is expected to reduce the action of the complement system, and so help reduce the likelihood of the transplanted organ being rejected.
www.ema.europa.eu/en/medicines/human/...Oh ja wie vermeld deze toepassing al geruime tijd?
A CT
B fanaat
C Janssen&Janssen
D DM
E de Rus
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