UCB finds a way forward for Cimzia for RA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
UCB will not have to conduct an additional study to support a rheumatoid arthritis indication for Cimzia (certolizumab); the firm recently met with FDA to clarify the requirements needed for the expanded approval. Further analysis of existing data and a new safety update are required. UCB Chief Medical Officer Iris Loew-Friedrich said to anticipate the submission of their full response in the second quarter of this year. The firm received a "complete response" letter in January requesting more safety data on the tumor necrosis factor inhibitor, which is already approved for Crohn's disease (1"The Pink Sheet" DAILY, Jan. 5, 2009)
You may also be interested in...
Cimzia Rheumatoid Arthritis Approval Held Up By Safety Request
UCB receives “complete response” letter from FDA on second indication for the biologic, approved for Crohn’s disease with a REMS.
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.