Health Protection Agency welcomes the Approval of ERWINAZE™ Biologics License Application for Treatment of Acute Lymphoblastic Leukemia
pharmafile | December 7, 2011 | News story | Manufacturing and Production |
Salisbury, UK – 18th November 2011 –the Health Protection Agency (HPA) today welcomed the news that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for ERWINAZE™. The application was made by the HPA’s development and commercialisation partner for Erwinaze™ – EUSA Pharma. ERWINAZE™ (asparaginase Erwinia chrysanthemi) is used in the treatment of acute lymphoblastic leukaemia in patients with hypersensitivity to E. coli-derived asparaginase. ERWINAZE™ is currently approved in a number of countries, including Canada, the UK and several European Union member states.
Dr Roger Hinton HPA’s Head of Development & Production, commented, “The HPA is extremely pleased with the announcement of the FDA’s approval of ERWINAZE™. We have worked diligently to achieve this goal alongside our partners EUSA Pharma, which is key in making this important therapy readily available as rapidly as possible. Children with acute lymphoblastic leukemia may develop allergy to current asparaginase products and ERWINAZE™ provides a key therapeutic alternative for this gravely ill group in several countries around the world.
“The HPA has been producing ERWINASE® for a number of years and it is currently available in many countries around the world, including the UK. This treatment has helped save the lives of thousands of children and today’s approval is very positive news for patients in the U.S.
“ERWINAZE® is just one of the biopharmaceutical products produced by HPA at its manufacturing facilities at Porton Down. The agency is responsible for the development and production of a number of products which are produced both in house and in partnership with others. We will continue to offer this service to allow our expertise to be applied to others in the field of translational development of biopharmaceuticals.”
About acute lymphoblastic leukemia
Acute lymphoblastic leukemia (ALL) is the most commonly diagnosed childhood cancer. ALL predominantly affects children and adolescents, with approximately 2,900 patients under the age of 20 diagnosed in the U.S. each year and around 400 in the UK. ALL treatment is complex, involving a number of stages and many drugs, and includes asparaginase as an essential component of current protocols. Paediatric treatment is often highly successful, with remission rates of over 95% and 75 – 85% of treated children surviving for at least five years without recurrence of leukemia.
About ERWINAZE™
ERWINAZE™ (US Trademark) ERWINASE® (Trademark outside of the US) is an asparaginase enzyme that depletes the level of the amino acid asparagine in the bloodstream. Asparagine is essential for cell growth, and its removal from the blood inhibits the growth of cells associated with acute lymphoblastic leukemia. Asparaginase products are derived from bacteria, and approximately 15 – 20 percent of patients develop hypersensitivity to modern products derived from Escherichia coli. ERWINAZE™, which is produced by Erwinia chrysanthemi, is immunologically distinct from these therapies and is suitable for patients with hypersensitivity to E. coli-derived treatments.
About HPA
The Health Protection Agency is an independent UK organisation that was set up by the government in 2003 to protect the public from threats to their health from infectious diseases and environmental hazards. In April 2013, subject to the usual approvals procedures for establishing new bodies, the Health Protection Agency will become part of a new organisation called Public Health England, an executive agency of the Department of Health. To find out more, visit our website: www.hpa.org.uk or follow us on Twitter @HPAuk.
Contact
For more information please contact the national HPA press office at Colindale on 0208 327 7901 or email colindale-pressoffice@hpa.org.uk. Out of hours the duty press officer can be contacted on 0208 200 4400.
