UCB GETS POSITIVE RESULTS FROM TWO CIMIZIA PHASE III STUDIES.UCB has announced positive top-line results for signs and symptoms from two new phase III studies for CIMZIA(TM) (certolizumab pegol), the first Fab' fragment anti-TNF (Tumor Necrosis Factor tumor necrosis factor n. Abbr. TNF A protein that is produced in the presence of an endotoxin, especially by monocytes and macrophages, is able to attack and destroy tumor cells, and exacerbates chronic inflammatory diseases. ), in the treatment of rheumatoid arthritis. In both the RAPID 1 (027) and RAPID 2 (050) studies CIMZIA(TM), in combination with methotrexate methotrexate, drug used in halting the growth of actively proliferating tissues. Introduced in the 1950s, it is used in the treatment of leukemia, psoriasis, and non-Hodgkin's lymphoma. , demonstrated superiority to placebo, and a statistically significant improvement in the signs and symptoms of rheumatoid arthritis as measured by all American College of Rheumatology (ACR See riser card. ) scores: ACR20, 50, and 70. Further details on the results from the RAPID studies, including data on the prevention of structural damage, will be released during the first quarter of 2007. UCB also provided an update on the status of the US approval of CIMZIATM in the treatment of Crohn's disease
The treatment of Crohn's disease is sequential: to treat acute disease, and then to maintain remission. Treatment initially involves the use of medications to treat any infection and to reduce inflammation. . UCB has received a Complete Response Letter from the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) requesting additional information and clarification on data submitted in its Biologics License Application (BLA) for the approval of CIMZIATM in Crohn's disease. "We have absolute confidence in both the efficacy and tolerability profile of CIMZIATM, and in gaining US approval" said Melanie Lee, executive vice president R&D for UCB. "We are extremely pleased by the rheumatoid arthritis results and will work closely with the FDA to clarify any questions that they have, or may have, regarding CIMZIATM for the treatment of Crohn's disease and rheumatoid arthritis." About UCB UCB is a global biopharmaceutical company dedicated to the research, development and commercialization of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders Nervous system disorders A satisfactory classification of diseases of the nervous system should include not only the type of reaction (congenital malformation, infection, trauma, neoplasm, vascular diseases, and degenerative, metabolic, toxic, or deficiency , allergy / respiratory diseases, immune and inflammatory disorders and oncology - UCB focuses on securing a leading position in severe disease categories. Employing over 8,300 people in 40 countries, it has worldwide headquarters located in Brussels, Belgium, UCB is listed on the Euronext Brussels Exchange. For more information, visit http://www.ucb-group.com. |
|
||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion