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On October 26, 2016, Bronger Ingeham announced the key phase III clinical findings of BI 695501, a biosypolor-like drug approved in the United States for Symele ® and a candidate for Someile ® (Adamo monomatics) approved in the European Union. BI 695501 reached the end of the main effectiveness of clinical studies: the eoculative eocuminance of Someile's disease was established in patients with ® rheumatoid arthritis (RA). Secondary endpoints have also been reached: BI 695501 ® similar effectiveness, safety and immunogenicity.
"This milestone paves the way for the submission of BI 695501 for regulatory approval in key markets such as the United States and Europe," said Dr. Sandeep Athalye, Vice President and Director of Clinical Development and Medical Affairs for Biosynthic Drugs at Grigg Ingham. "Focusing on BI 695501 and other biosypolytic drugs, we recognize the growing importance of biosynthetics in providing patients and doctors with high-quality treatment options while contributing to the long-term sustainability of the healthcare system."
This Phase III clinical study was a randomized, double-blind, parallel group, multiple administration, and positive control drug study, in 645 cases diagnosed with moderate to severe active rheumatoid arthritis, and was followed by patients treated with methotrexate. Each participant was randomly assigned to receive BI 695501 or ®, once every two weeks for a total of 48 weeks. The main purpose of this clinical study was to establish the statistical equidresity of BI 695501 and Symele ® in terms of effectiveness in patients with active rheumatoid arthritis, measuring the proportion of patients who met the ACR20 (American Rheumatology Society 20) standard in weeks 12 and 24 compared to the baseline.
the secondary purpose of this clinical study is to compare BI 695501 with other effectiveness indicators (DAS28), safety, and immunogenicity of Symele ®.
results of this clinical study will be presented and reported at future medical conferences.
