Media Release
Basel, 15 December 2006
Roche offers the FDA additional Mircera data
FDA accepts and grants three month extension to the review
Roche today announced that it has submitted additional data to the FDA to support its Biologic Licence Application (BLA) for Mircera. These data offered are intended to provide as comprehensive an understanding of Mircera as is possible to assist the FDA in completing the review process. As a result of this action, the FDA has granted Roche a three month extension to the review period.
“The newly available Mircera data that we have proactively submitted will help to give the FDA additional clarity in key areas that the FDA is monitoring with already available anti-anaemia agents,” said Eduard Holdener, Global Head Pharma Development. He added: “We want to ensure that our application to the FDA is as robust as possible in an evolving regulatory environment and we are confident that the additional data submitted will facilitate a positive review of Mircera.”
Roche is seeking an indication for Mircera in the treatment of anaemia associated with chronic kidney disease (CKD) including patients on dialysis or not on dialysis. The BLA submitted to the FDA is based on data from all six studies that comprise the Phase III clinical program. This included treating anaemia in previously untreated patients and maintaining haemoglobin (Hb) after conversion from epoetin alfa/beta or darbepoetin alfa. The program consisted of two treatment/correction and four conversion/maintenance studies of both intravenous and subcutaneous Mircera at extended administration intervals of up to once monthly.
About Mircera
Mircera is a new anti-anaemia agent. It is both functionally and structurally unique. It is the first continuous erythropoietin receptor activator and it differs from rhuEPO by being a complex, chemically synthesized erythropoiesis stimulating agent. Mircera differs from existing ESAs by its mechanism of action; long half-life; and by being the first new anti-anaemia agent which was specifically designed to provide long dosing intervals of up to once a month. If approved, it will be the first agent to correct anaemia in chronic kidney disease patients on dialysis and not on dialysis with dosing once every two weeks and the first to maintain these patients on dosing intervals up to once a month. Mircera is also the first drug to have compared itself in clinical trials against all available agents: epoetin alfa, beta and darbepoetin alfa.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (www.roche.com).
Roche offers the FDA additional Mircera data
FDA accepts and grants three month extension to the review
Roche today announced that it has submitted additional data to the FDA to support its Biologic Licence Application (BLA) for Mircera. These data offered are intended to provide as comprehensive an understanding of Mircera as is possible to assist the FDA in completing the review process. As a result of this action, the FDA has granted Roche a three month extension to the review period.
“The newly available Mircera data that we have proactively submitted will help to give the FDA additional clarity in key areas that the FDA is monitoring with already available anti-anaemia agents,” said Eduard Holdener, Global Head Pharma Development. He added: “We want to ensure that our application to the FDA is as robust as possible in an evolving regulatory environment and we are confident that the additional data submitted will facilitate a positive review of Mircera.”
Roche is seeking an indication for Mircera in the treatment of anaemia associated with chronic kidney disease (CKD) including patients on dialysis or not on dialysis. The BLA submitted to the FDA is based on data from all six studies that comprise the Phase III clinical program. This included treating anaemia in previously untreated patients and maintaining haemoglobin (Hb) after conversion from epoetin alfa/beta or darbepoetin alfa. The program consisted of two treatment/correction and four conversion/maintenance studies of both intravenous and subcutaneous Mircera at extended administration intervals of up to once monthly.
About Mircera
Mircera is a new anti-anaemia agent. It is both functionally and structurally unique. It is the first continuous erythropoietin receptor activator and it differs from rhuEPO by being a complex, chemically synthesized erythropoiesis stimulating agent. Mircera differs from existing ESAs by its mechanism of action; long half-life; and by being the first new anti-anaemia agent which was specifically designed to provide long dosing intervals of up to once a month. If approved, it will be the first agent to correct anaemia in chronic kidney disease patients on dialysis and not on dialysis with dosing once every two weeks and the first to maintain these patients on dosing intervals up to once a month. Mircera is also the first drug to have compared itself in clinical trials against all available agents: epoetin alfa, beta and darbepoetin alfa.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (www.roche.com).
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