Stuurman65 schreef op 29 februari 2016 12:17:
[...]
Klopt, maar dit telt ook mee !
Prof. Bruno Giannetti, MD, PhD, Pharming’s COO commented: “This EU label change will now also give adolescent in the EU the long awaited access to treat their HAE attacks
with a non- blood derived C1- inhibitor and in addition, the positive CHMP opinion confirms the well-established
safety profile of RUCONEST® , based on a database of a dozen controlled clinical trials as well as more than 12,000 post-marketing doses of RUCONEST® provided to HAE patients. After adoption of the CHMP opinion by the European Commission,
this will remove the burden on patients and doctors to perform testing prior to and after treatments with RUCONEST® and enable emergency treatment with Ruconest® for HAE attacks in previously untreated HAE patients. HAE patients previously dependent on plasma derived C1INH therapies, including adolescents,
will be able to receive RUCONEST® with the benefit of eliminating risks of exposure to known blood borne pathogens, such as Hepatitis A, B, C, E, HIV, and CJD, as well as continuously (re)-emerging pathogens, such as the recent ZIKA virus.”