Halozyme Therapeutics Inc (HALO)

[rod5247]

Baxalta Announces Update to Product Information for HyQvia in Europe, Enhancing Availability for More Patients with Immunodeficiencies







• HyQvia (Human Normal Immunoglobulin (10%), Recombinant Human Hyaluronidase) is the only subcutaneous IG treatment that can be administered up to once monthly with one needle in a single site to treat primary and certain secondary immunodeficiencies
• Changes to product information enhance access for more patients with data supporting use during pregnancy
• HyQvia is now available in 14 countries, and Baxalta continues to pursue additional indications and approvals

BANNOCKBURN, Ill., September 16, 2015 – Baxalta Incorporated (NYSE:BXLT), a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, has announced an update to the European product information for HyQvia (Human Normal Immunoglobulin (10%), Recombinant Human Hyaluronidase), easing restrictions related to pregnancy, fertility and lactation based on supplemental preclinical data supporting its safety profile.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recently provided a positive opinion on the HyQvia product information update after a review of additional preclinical data. HyQvia product labeling in Europe no longer differs in terms of pregnancy, lactation and fertility from other immunoglobulins and there is no longer a requirement to distribute educational materials to health professionals and patients on this topic. HyQvia's U.S. label does not cite pregnancy-related restrictions and is not affected by these changes.

Baxalta initially obtained marketing authorization in Europe in May 2013 for the use of HyQvia as replacement therapy for adult patients with primary and certain secondary immunodeficiencies. Patients with immunodeficiencies are missing or have malfunctioning components of their immune systems, placing them at greater risk for recurring infections, longer recovery from illness and more risk of potentially life-threatening complications.1

“As more patients with immune deficiencies gain experience with HyQvia, this will build on the ongoing collection of real world safety and efficacy data,” said Stephen Jolles, M.D. PhD, consultant clinical immunologist at the University Hospital of Wales in the U.K. “This community continues to seek new treatment options for patients who require clinical efficacy and are also looking for ways to reduce the burden of their disease on their daily lives with less frequent dosing and fewer needle sticks compared to other subcutaneous treatments.”

"This product information update is a strong reflection of the robust preclinical data that supports the safety and efficacy of HyQvia and will be a useful consideration for physicians seeking the right option to treat their patients with PI in Europe," said John Orloff, M.D., executive vice president, head of Research & Development and chief scientific officer, Baxalta. “Baxalta is committed to exploring opportunities to expand the value of HyQvia for more patients through continued geographic expansion and new indications, with the goal of reducing the burden for patients worldwide.”

HyQvia was developed with a focus on addressing unmet treatment needs for patients. The therapy offers a demonstrated safety and efficacy profile while delivering a full dose of treatment via one needle in one infusion site, up to once a month for many patients, and can be self-administered at home after appropriate training. Since the first launch of HyQvia in July 2013, Baxalta has introduced the treatment in 14 countries so far. As part of the company’s ongoing efforts to meet the needs of PI patients, Baxalta plans to apply for a pediatric indication in Europe later this year.

About HyQvia (Human Normal Immunoglobulin (10%), Recombinant Human Hyaluronidase) in Europe

Indication and Usage
In Europe, HyQvia is indicated as replacement therapy in adults (>18 years) in primary immunodeficiency syndromes and in myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.

For more information on HyQvia in Europe, please visit www.ema.europa.eu.