Shire plc, a leading global biotechnology company, has announced that the company is launching a pediatric indication for HyQvia (Human Normal Immunoglobulin (10%), Recombinant Human Hyaluronidase) across Europe. This follows the recent marketing authorisation granted by the European Commission to Baxalta, now part of Shire, in June 2016.
HyQvia is a replacement therapy to treat 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, in some cases making it more difficult to fight off infections. It is estimated that as many as six million children and adults may be affected by Primary Immunodeficiencies (PI) worldwide.
Shire is commercially introducing the new indication across the member states of Europe, starting this month with Germany, The Netherlands, Ireland, Greece, Slovakia, Denmark, Sweden and Norway.
“We are pleased to bring pediatric patients a new therapeutic option as we build on our broad immunoglobulin (IG) 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.”
HyQvia was developed with a focus on addressing unmet treatment needs for patients. The treatment, which does not include proline, offers a demonstrated safety and efficacy profile (based on the pivotal study among 87 patients) as a two-part infusion combining Halozyme’s recombinant human hyaluronidase with immunoglobulin (Ig). HyQvia delivers a full dose of treatment in 1-2 infusion sites, up to once a month (up to every four weeks) for many patients, and can be self-administered at home after appropriate training. The flexibility of the treatment approach was noted by patient feedback during the pivotal study, in which 79 percent of patients and their caregivers (those <18) preferred to continue treatment with HyQvia rather than an intravenous or conventional subcutaneous treatment.
Shire (Baxter at the time) initially obtained marketing authorization for HyQvia in Europe in May 2013. The product is also licensed in the US, in Puerto Rico, and Australia, and currently under review in Brazil, Columbia, Mexico, and Argentina.
In Europe today, HyQvia is indicated as replacement therapy in all patients in primary immunodeficiency syndromes with impaired antibody production, hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia (CLL), in whom prophylactic antibiotics have failed or are contra-indicated, hypogammaglobulinaemia and recurrent bacterial infections in multiple myeloma (MM) patients, hypogammaglobulinaemia in patients pre- and post-allogeneic hematopoietic stem cell transplantation (HSCT).