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Baxalta Receives Positive Opinion from Europe's CHMP for HYQVIA to Treat Pediatric PatientsNOT FOR U.S. AUDIENCES Baxalta Incorporated (NYSE:BXLT), a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA (News - Alert)) has adopted a positive opinion recommending marketing authorization for pediatric indication of HyQvia (Human Normal Immunoglobulin (10%), Recombinant Human Hyaluronidase), expanding on its use in adult patients. The CHMP's positive opinion will now be referred to the European Commission (EC), which grants marketing authorization for medicines in the European Union. Upon EC approval, HyQvia will be authorized for pediatric use in all 28 EU member states plus Iceland and Norway. "We are pleased to receive a positive CHMP opinion for a pediatric indication of HyQvia. This is a significant milestone in increasing access to a treatment option for patients with immunodeficiencies who can benefit from once-monthly dosing," said John Davis, M.D., M.P.H., vice president, Clinical Research and Development and global therapeutic area head, Immunology, Baxalta. "At Baxalta, we are committed to expanding the availability of HyQvia to more patients through continued expansion in new geographies and new therapeutic indications, with the goal of reducing the burden for patients worldwide." 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 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 in 1-2 infusion sites, up to once a month (every three to four weeks) for many patients, and can be self-administered at home after appropriate training. Since the first launch, HyQvia is now available in 14 countries across Europe. About HyQvia (Human Normal Immunoglobulin (10%), Recombinant Human Hyaluronidase) in Europe Indication and Usage In Europe, today 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 isit www.ema.europa.eu. Important Risk Information HyQvia must not be used by patients with a hypersensitivity to human immunoglobulins, especially in very rare cases of IgA deficiency when the patient has antibodies against IgA. HyQvia must not be used by patients with a systemic hypersensitivity to hyaluronidase or recombinant human hyaluronidase. HyQvia must not be used by patients with a hypersensitivity to any of the excipients, including glycine. HyQvia must not be given intravenously. Patients should be closely monitored and carefully observed for any adverse reactions throughout the infusion period, particularly patients starting with HyQvia treatment. In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped. The treatment required depends on the nature and severity of the adverse reaction. In case of shock, standard medical treatment for shock should be implemented. Thromboembolic events (e.g. myocardial infarction, cerebral vascular accident, deep vein thrombosis, and pulmonary embolism), renal dysfunction/failure, aseptic meningitis syndrome, and hemolysis have been observed with IG 10% administered intravenously and cannot be excluded with use of HyQvia. Thrombotic events and haemolysis have also been reported in association with the subcutaneous administration of immunoglobulin products. Human normal immunoglobulin and human serum albumin (stabilizer of the recombinant human hyaluronidase) are produced from human plasma and may carry a risk of transmitting infectious agents. About Primary Immunodeficiency Primary immunodeficiencies (PI) are a group of more than 300 disorders in which part of the body's immune system is missing or does not function properly. Normally, the immune system protects the body from pathogenic microorganisms like bacteria, viruses, and fungi, which can cause infectious diseases. When any part of a person's immune system is absent or dysfunctional, they are susceptible to infections and may take longer to recover from infections. When a defect in the immune system is inherited, it is called primary immune deficiency. It is estimated that as many as six million children and adults may be affected by PI worldwide.2 About Baxalta Baxalta Incorporated (NYSE: BXLT) is a global biopharmaceutical leader developing, manufacturing and commercializing therapies for orphan diseases and underserved conditions in hematology, immunology and oncology. Driven by passion to make a meaningful impact on patients' lives, Baxalta's broad and diverse pipeline includes biologics with novel mechanisms and advanced technology platforms such as gene therapy. Launched in 2015 following separation from Baxter International, Baxalta's heritage in biopharmaceuticals spans decades. Baxalta's therapies are available in more than 100 countries and it has advanced biological manufacturing operations across 12 facilities, including state-of-the-art recombinant production and plasma fractionation. Headquartered in Northern Illinois, with its Global Innovation Center in Cambridge, Mass., Baxalta employs 17,000 employees worldwide. Forward-Looking Statements This release includes forward-looking statements concerning HYQVIA, including expectations with regard to future regulatory actions and potential impact on patients. Such statements are made of the date that they were first issued and are based on current expectations, beliefs and assumptions of management. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond Baxalta's control and which could cause actual results to differ materially from those in the forward-looking statements, including the following: clinical trial results; satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; product quality, manufacturing or supply issues; patient safety issues; and other risks identified in Baxalta's Annual Report on Form 10-K and other Securities and Exchange Commission filings, all of which are available on Baxalta's website. Baxalta expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. References
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