UCB plans to utilise the appeal process to request a CHMP re-examination of the submission
BRUSSELS, Belgium | November 16, 2007 | UCB announced today that it has been informed by the European Medicines Agency (EMEA) that the Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion on the market authorisation application (MAA) in the EU for CIMZIA� certolizumab pegol) in the treatment of patients with Crohn’s disease.
UCB plans to utilise the appeal process to request a CHMP re-examination of the submission. A decision is expected during the first half of 2008.
"UCB is disappointed by the CHMP decision, but remains confident in the efficacy and tolerability of CIMZIA�. UCB will continue to work with the CHMP to address the Committee’s concerns to obtain its endorsement to allow this treatment option to be available to people suffering from Crohn’s disease." said Melanie Lee, Executive Vice President Research & Development of UCB.
About CIMZIA
CIMZIA� is the only PEGylated anti-TNF (Tumour Necrosis Factor). CIMZIA� has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha. Over the past decade, TNF-alpha has emerged as a major target of basic research and clinical investigation. This cytokine plays a key role in mediating pathological inflammation, and excess TNF-alpha production has been directly implicated in a wide variety of diseases.
UCB filed a Biologics License Application (BLA) with the Food and Drug Administration (FDA) for CIMZIA� in the treatment of Crohn’s disease on February 28, 2006. CIMZIA� was approved in Switzerland for the treatment of Crohn’s disease in September 2007. Preparation for a regulatory submission for CIMZIA� in the treatment of rheumatoid arthritis in the U.S. is ongoing.
The MAA was based on the pivotal PRECiSE studies involving over 1,500 patients with Crohn’s disease.[1],[2]
References
1. Sandborn WJ et al. Certolizumab pegol for the treatment of Crohn’s disease. NEJM 2007;357:228-38.
2. Schreiber S et al. Maintenance therapy with certolizumab pegol for Crohn’s disease. NEJM 2007;357:239-50.
About UCB
UCB, Brussels, Belgium (www.ucb-group.com) is a global leader in the biopharmaceutical industry dedicated to the research, development and commercialisation of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology. UCB focuses on securing a leading position in severe disease categories. Employing more than 10,000 people in over 40 countries, UCB achieved revenue of 3.5 billion euro in 2006 on a pro forma basis. UCB S.A. is listed on the Euronext Brussels Exchange and, through its affiliate, owns approx. 89% of the shares of SCHWARZ PHARMA AG. SCHWARZ PHARMA AG (Monheim, Germany).
SOURCE: UCB
Post Views: 120
UCB plans to utilise the appeal process to request a CHMP re-examination of the submission
BRUSSELS, Belgium | November 16, 2007 | UCB announced today that it has been informed by the European Medicines Agency (EMEA) that the Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion on the market authorisation application (MAA) in the EU for CIMZIA� certolizumab pegol) in the treatment of patients with Crohn’s disease.
UCB plans to utilise the appeal process to request a CHMP re-examination of the submission. A decision is expected during the first half of 2008.
"UCB is disappointed by the CHMP decision, but remains confident in the efficacy and tolerability of CIMZIA�. UCB will continue to work with the CHMP to address the Committee’s concerns to obtain its endorsement to allow this treatment option to be available to people suffering from Crohn’s disease." said Melanie Lee, Executive Vice President Research & Development of UCB.
About CIMZIA
CIMZIA� is the only PEGylated anti-TNF (Tumour Necrosis Factor). CIMZIA� has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha. Over the past decade, TNF-alpha has emerged as a major target of basic research and clinical investigation. This cytokine plays a key role in mediating pathological inflammation, and excess TNF-alpha production has been directly implicated in a wide variety of diseases.
UCB filed a Biologics License Application (BLA) with the Food and Drug Administration (FDA) for CIMZIA� in the treatment of Crohn’s disease on February 28, 2006. CIMZIA� was approved in Switzerland for the treatment of Crohn’s disease in September 2007. Preparation for a regulatory submission for CIMZIA� in the treatment of rheumatoid arthritis in the U.S. is ongoing.
The MAA was based on the pivotal PRECiSE studies involving over 1,500 patients with Crohn’s disease.[1],[2]
References
1. Sandborn WJ et al. Certolizumab pegol for the treatment of Crohn’s disease. NEJM 2007;357:228-38.
2. Schreiber S et al. Maintenance therapy with certolizumab pegol for Crohn’s disease. NEJM 2007;357:239-50.
About UCB
UCB, Brussels, Belgium (www.ucb-group.com) is a global leader in the biopharmaceutical industry dedicated to the research, development and commercialisation of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology. UCB focuses on securing a leading position in severe disease categories. Employing more than 10,000 people in over 40 countries, UCB achieved revenue of 3.5 billion euro in 2006 on a pro forma basis. UCB S.A. is listed on the Euronext Brussels Exchange and, through its affiliate, owns approx. 89% of the shares of SCHWARZ PHARMA AG. SCHWARZ PHARMA AG (Monheim, Germany).
SOURCE: UCB
Post Views: 120
