Advertisement

Topics

Citing Patient Deaths, FDA Panel Faults Safety Data for J&J Arthritis Candidate

05:50 EDT 3 Aug 2017 | Genetic Engineering News

An FDA advisory panel has concluded that the safety profile of the Johnson & Johnson(J&J)-sponsored rheumatoid arthritis candidate sirukumab did not support approval by the agency, even though the drug’s efficacy was found sufficient for authorization. The FDA’s Arthritis Advisory Committee yesterday voted 12 to 1 against recommending approval based on the safety data, which showed that of the 35 patient deaths reported in sirukumab clinical trials, all but one (34) occurred in patients treated with sirukumab. A total 2,926 patients were treated with either 50 mg or 100 mg doses of sirukumab in five Phase III trials. Thirty-one of the 35 deaths occurred within 16 weeks of last dose of study agent, the FDA disclosed in the staff-prepared Briefing Document on sirukumab submitted to the Committee. The main causes of death, according to the Document, were cardiovascular events (13 patients), serious infections (8), malignancies (6), ...

Original Article: Citing Patient Deaths, FDA Panel Faults Safety Data for J&J Arthritis Candidate

NEXT ARTICLE

More From BioPortfolio on "Citing Patient Deaths, FDA Panel Faults Safety Data for J&J Arthritis Candidate"

Quick Search
Advertisement
 

Relevant Topic

Biotechnology Business
Alliances Astrazeneca Bioethics Boehringer Clinical Research Organization Collaborations GSK Johnson & Johnson Lilly Merck Mergers and Acquisitions Nexium Novartis Pfizer Roche Sanofi ...