Shire is rolling out a paediatric indication for its immunodeficiency drug HyQvia across Europe, following a regulatory green light earlier this year.
Baxalta, now part of the Shire group, initially obtained marketing clearance in May 2013 for the use of HyQvia as replacement therapy for adults with primary and certain secondary immunodeficiencies, a group of disorders in which part of the body's immune system is missing or does not function properly. The drug is also licensed in the US and other regions.
Now the once-monthly replacement therapy, which can be self-administered at home, will also be available in Europe to younger patients suffering from primary immunodeficiencies, with first launches scheduled for Germany, The Netherlands, Ireland, Greece, Slovakia, Denmark, Sweden and Norway.
"We are pleased to bring paediatric patients a new therapeutic option as we build on our broad immunoglobulin portfolio for patients with immune deficiencies," said Ueli Fankhauser, head, Global Product Strategy. "We intend to expand the availability of HyQvia to more patients in additional geographies, with the goal of reducing the treatment burden for patients worldwide."
It is estimated that as many as six million children and adults world-wide may be affected by primary immunodeficiencies, a group of more than 300 different disorders cause by a defective immune system that is genetically determined.