On 21 September 2016, the European Medicines Agency (“EMA”) issued a press release to announce that the assessment it carried out along with competent authorities in the EU Member States have confirmed that patients who take plasma-derived or urine-derived medicines do not face increased risk of contamination with the Zika virus.
Plasma-derived medicines, manufactured from human blood, are used to treat some serious blood conditions and to help fight infections. They include coagulation factors, that help blood to clot, and immunoglobulins, proteins that help antibodies develop.
Urine-derived medicines, manufactured from pooled human urine, include certain hormone-based treatments and urokinase products to help break up blood clots.
Therefore, both plasma- and urine-derived medicines are drugs produced from body fluids, which might be sourced from parts of the world where the Zika virus is prevalent. The assessment of the EU regulators was intended to determine, in case of plasma or urine coming from donors who had contracted the Zika virus, that there is no risk of the virus contaminating the final product and thus affecting the patients being treated with the product.
The EU regulators assessment
EMA’s Committee for Medicinal Products for Human Use (CHMP) assessed the potential risk arising from Zika virus for plasma-derived medicinal products. The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), responsible for the examination and coordination of questions relating to the marketing authorisation of human medicines in two or more EU Member States, coordinated the assessment by EU Member States on the potential risk from Zika virus for urine-derived medicinal products.
The CHMP concluded in its assessment that manufacturing processes used for plasma-derived products efficiently inactivate or remove the virus from the final product. These manufacturing processes include the use of solvents or detergents, pasteurisation (liquid heat inactivation) and virus filtration. As the CHMP considers these processes to be sufficient to ensure that patients are not contaminated with the Zika virus, no additional safety measures such as the testing or exclusion of certain plasma donors was considered necessary.
As regards urine-derived products, the CMDh concluded its assessment with the finding that the manufacturing processes for these products, containing complementary steps with inactivation/removal capacity, are sufficient to ensure Zika virus safety of these products. Thus, no additional safety measures such as the screening or exclusion of certain plasma donors was considered necessary for these products as currently authorised in the EU. The CMDh however states that, in view of the current spread of Zika virus, product-specific risk assessment should be updated on a regular basis.
The conclusions of these assessments on the virus safety of plasma- and urine-derived medicines can be found in the report from the CHMP’s Biologics Working Party (BWP) dated 21 September 2016.
For further information visit: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2016/09/WC500213035.pdf