EMA, The European Drug Regulator, Published a Draft CHMP position Statement on Creutzfeldt-Jakob Disease and Plasma-Derived and Urine-Derived Medical Products
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This is the second revision of the CPMP2 Position Statement on “Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products” (EMEA/CPMP/BWP/2879/02) published in February 2003 and revised in June 2004 and XXX 2010, which replaced the CPMP Position Statement on “New variant CJD and plasma-derived medicinal products” (CPMP/201/98) issued in February 1998.
Cumulative epidemiological evidence does not support transmission of sporadic, familial and iatrogenic Creutzfeldt-Jakob disease (CJD) by plasma-derived medicinal products. There is no change to the previous CHMP position that recall of plasma-derived medicinal products is not justified where a donor is later confirmed as having sporadic, familial or iatrogenic CJD.
Variant CJD (vCJD) is an emerging disease and the eventual number of cases of the disease is uncertain. There is a wider distribution and higher level of infectivity/abnormal prion protein in peripheral tissues than is seen with sporadic CJD. Four instances of apparent iatrogenic vCJD infection by blood transfusion in man in the UK provide strong evidence that vCJD is transmissible through blood transfusion. In 2009, the agent was detected in a haemophilia A patient who received intermediate purity FVIII prepared from pooled plasma sourced in the UK before 1998.
Residence in the UK is a recognised risk factor for vCJD and has led to the UK deciding to no longer fractionate from UK plasma. It is consistent with this decision to exclude donors who have spent long periods in the UK during the risk period from donating blood/plasma for fractionation. It is recommended that donors who have spent a cumulative period of 1 year or more in the UK between the beginning of 1980 and the end of 1996 are excluded from donating blood/plasma for fractionation.
There is no recommendation to recall batches if information that would have excluded a donor based on his/her stay in the UK becomes available post-donation, since this is a very conservative precautionary measure.
Available data indicate that the manufacturing processes for plasma-derived medicinal products would reduce vCJD infectivity if it were present in human plasma. Manufacturers are required to estimate the potential of their specific manufacturing processes to reduce infectivity using a step-wise approach. It is recommended that manufacturers consult the relevant competent authorities at each of the milestones in this estimation. CHMP and its Biotechnology Working Party (BWP) will keep progress with these recommendations and the actions to be taken under review.
In support of this recommendation, CHMP and BWP, with the involvement of external experts, have developed guidance on how to investigate manufacturing processes with regard to vCJD risk and CHMP and BWP are available to discuss issues that might arise.
The rationale for this position is that if, in the future, further cases of vCJD occur in countries collecting blood and plasma for the manufacture of plasma-derived medicinal products, a process previously shown to be able to reduce TSE infectivity will provide reassurance on the safety of past products, and could help to justify continuing fractionation.
Low levels of infectious TSE agents have been detected in the urine of scrapie-infected rodents and in the urine of deer with Chronic Wasting Disease. However, there is no epidemiological evidence of CJD or vCJD transmission by urine derived medicinal products. A general review of manufacturing processes for urine-derived medicinal products indicates that it is feasible to apply donor selection criteria when a product is derived from a relatively small and well-defined donor population. In addition, it indicates that manufacturing processes have at least one step that might be theoretically capable of reducing TSE infectivity if it were present in the starting material. It is noted that urine-derived medicinal products are not sourced from urine collected in the UK.
On the basis of this review and other considerations, the use of exclusion criteria for selection for a urine donor panel is encouraged, as a precautionary measure, where feasible. The same exclusion criteria should be applied with respect to CJD and vCJD as used for blood/plasma donors providing starting material for the manufacture of plasma-derived medicinal products but, unlike blood/plasma donors, these criteria would not be checked at each donation. Manufacturers of urine-derived medicinal products are recommended to evaluate the capacity of the manufacturing process to reduce/eliminate TSE agents by following a similar approach to that for plasma-derived medicinal products.
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