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Janssen Receives Complete Response Letter From U.S. FDA For Sirukumab Biologics License Application | ||||||||||||||||||
By: PR Newswire Association LLC. - 22 Sep 2017 | Back to overview list |
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HORSHAM, Pa., Sept. 22, 2017 /PRNewswire/ -- Janssen Biotech, Inc. (Janssen) announced today that it has received a complete response letter from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) seeking approval of sirukumab for the treatment of moderately to severely active rheumatoid arthritis (RA). The complete response letter indicates additional clinical data are needed to further evaluate the safety of sirukumab in the treatment of moderately to severely active RA. "We are disappointed by this development as we feel the data accumulated to date support the efficacy and safety of sirukumab in the treatment of moderately to severely active rheumatoid arthritis," said Newman Yeilding, M.D., Head of Immunology Development, Janssen Research & Development, LLC. "We believe sirukumab represents an important therapeutic option for patients living with rheumatoid arthritis, especially for those individuals who cycle through multiple treatments and continue to struggle to find an effective option for a potentially disabling disease. We are reviewing the details of the complete response letter and plan to have a follow-up discussion with the agency to gain a full understanding of FDA requirements for U.S. approval." On August 2, 2017, the FDA's Arthritis Advisory Committee did not recommend approval of sirukumab for RA. Convened upon the request of the FDA, the committee reviews and evaluates safety and efficacy data of human products for use in the treatment of arthritis. The committee provides non-binding recommendations based on its evaluation; however, the FDA makes the final decision on approval of the drug. The sirukumab BLA, filed on September 23, 2016, included data from a global Phase 3 clinical development program inclusive of five studies and approximately 3,100 RA patients, including those who continued to have active disease despite previous use of disease-modifying anti-rheumatic drugs (DMARDs) and biologic treatments. About Sirukumab Sirukumab is currently under review by health authorities in Europe and Japan as a subcutaneous therapy for the treatment of adult patients with moderately to severely active RA. Janssen holds exclusive rights to commercialize sirukumab in Europe, the Middle East, Africa and Asia Pacific, and will regain exclusive, worldwide commercial rights in November 2017 from GSK. About Rheumatoid Arthritis About the Janssen Pharmaceutical Companies Cautions Concerning Forward-Looking Statements References
View original content with multimedia:http://www.prnewswire.com/news-releases/janssen-receives-complete-response-letter-from-us-fda-for-sirukumab-biologics-license-application-300524496.html SOURCE Janssen Biotech, Inc. |
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