Novo Nordisk Files for Regulatory Approval of Turoctocog Alfa for Haemophilia A in the US and EU
Novo Nordisk today announced the submission of the regulatory application for turoctocog alfa (NN7008) to the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Turoctocog alfa is a third-generation recombinant coagulation factor VIII intended for prevention and treatment of bleeding in people with haemophilia A.
"We are very excited about having reached this goal. Turoctocog alfa represents a new treatment alternative for people with haemophilia A and is one of the first important outcomes of the haemophilia research strategy we embarked upon in 2006," says Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
Turoctocog alfa demonstrates Novo Nordisk's commitment to the wider haemophilia community as the new alternative in factor VIII treatment. Based on the most advanced protein and purification technology, the product has been designed to expand reliability, safety and portability for people with haemophilia A.
The decision to apply for marketing authorisation for turoctocog alfa is based on the results of the clinical trials guardian™1 and guardian™3, which were completed in 2011. More than 200 people with haemophilia A around the world were enrolled, making guardian™ the largest clinical pre-registration trial program conducted in haemophilia A.
The phase 3 trials included previously treated adults and children with severe haemophilia A and demonstrated efficacy in preventing and treating bleeds with no development of inhibitors.
In the coming months, applications for regulatory approval in other countries
will be submitted.
Click here to read the Novo Nordisk Press Release dated October 16, 2012
FDA Approves Longer Storage for Bayer’s Kogenate® FS
In April, Bayer HealthCare Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved Kogenate® FS, a recombinant factor VIII therapy, for storage at room temperature (up to 77 degrees F) for up to one year. Kogenate® FS is indicated for the treatment of hemophilia A. The previous storage time at room temperature was three months.
“As convenience with medication is important to people with hemophilia A, we're pleased to offer a new storage temperature option, which complements other convenience features, including Grab and Go packaging with BIO-SET®, a compact and complete reconstitution system for Kogenate® FS,” said Paul Bedard, Vice President/General Manager, Hematology, Bayer HealthCare Pharmaceuticals. “This new option demonstrates Bayer’s ongoing commitment to the hemophilia A community.”
Source: PRNewswire, April 25, 2011
CSL Behring Receives NORD Corporate Award
Last month the National Organization for Rare Disorders (NORD) honored CSL Behring with its 2011 Corporate Award for “new treatments brought to market for patients with rare diseases.” The award was presented during the NORD Partners in Progress Celebration 2011 on May 17, at the Andrew W. Mellon Auditorium in Washington, DC.
CSL Behring develops and manufactures therapies for several types of bleeding disorders. In February 2011 the company's product Corifact, a plasma-derived factor XIII (FXIII) therapy, received U.S. Food and Drug Administration approval for the routine prophylactic treatment of congenital FXIII deficiency.
Factor XIII deficiency, a very rare disorder affecting approximately 150 people in the U.S, can be associated with prolonged, trauma-related bleeding. More severely affected patients are at risk for head bleeds. Women who go untreated risk spontaneous abortion. Men with the deficiency may show signs of infertility. Common symptoms include soft tissue bleeds, menorrhagia, joint bleeding and persistent bleeding during circumcision or at the site of the umbilical cord.
“CSL Behring is honored to receive this NORD Corporate Award,” said Paul Perreault, CSL Behring Executive Vice President for Worldwide Commercial Operations and incoming president. “People with rare diseases often face a host of challenges in being accurately diagnosed and in gaining ongoing access to appropriate medical care. CSL Behring focuses on these areas and partners with groups such as NORD to improve patients' lives. We commend NORD for their outstanding achievements and dedication to supporting people with rare diseases.”
NORD is a patient advocacy organization that advances the causes of people with rare diseases. It provides support for orphan product research used to treat serious conditions that affect fewer than 200,000 people. It develops and advocates on public policy issues before Congress and health agencies.
Source: CSL Behring news release dated May 17, 2011