Global Insight Perspective | |
Significance | The U.S. FDA has requested a new safety update for UCB's drug Cimzia (certolizumab pegol), including all clinical data, before the drug can be approved for treating rheumatoid arthritis. |
Implications | The request follows the addition of a black-box warning on Cimzia and other anti-TNF drugs in the United States. The FDA's move is characteristic of the agency's increasingly tough stance on drug safety. |
Outlook | Cimzia's existing U.S. indication for Crohn's disease will see its market share grow steadily, but the FDA's hesitancy over approving the drug in a new indication may have repercussions in other key markets where UCB is seeking regulatory backing. |
Belgian pharma giant UCB has received a new Complete Response Letter from the U.S. FDA, requesting additional safety information on Cimzia (certolizumab pegol) as a treatment for rheumatoid arthritis. More specifically, the FDA has asked UCB to resubmit all clinical data on Cimzia, including any new data generated since its Biologics License Application (BLA) was filed with the FDA last February. The agency has also called for a meeting between its representatives and those from UCB, to be held within the next 30 days; UCB has agreed to attend and has vowed to comply with the FDA, in order to secure U.S. approval for Cimzia in rheumatoid arthritis as soon as possible.
Cimzia is a pegylated anti-tumour necrosis factor (TNF) drug, which works by neutralising the pathophysiological effects of human TNF-alpha. It received U.S. approval in April 2008 as a treatment for Crohn's disease, but has twice been refused approval for this indication in Europe. UCB filed a marketing-authorisation application for Cimzia in rheumatoid arthritis with the European Medicines Agency (EMEA) in July 2008, and is currently awaiting a recommendation from the EMEA's Committee for Medicinal Products for Human Use.
The FDA's Complete Response Letter is the second sent to UCB in as many months. The first, issued in late December, ensured that Parkinson's disease drug patch Neupro (rotigotine) will remain off the market until UCB can guarantee a permanent fix to problems with the treatment's delivery system (see Belgium: 19 December 2008: FDA Complete Response Letter Insists UCB Must Fix Neupro's Delivery Problems Before Market Relaunch).
Outlook and Implications
The FDA's caution in approving Cimzia for a new indication is unsurprising, given the agency's recent safety crackdown on the anti-TNF drug class to which Cimzia belongs (see United States: 5 September 2008: Tough New Warnings for TNF Inhibitors from the FDA; Regulatory Concern on Fablyn Persists). However, with both Cimzia and Neupro viewed by UCB as being key growth drivers for the company's pharmaceutical pipeline, this delay in the approval process for Cimzia's second U.S. indication is precisely the sort of development that the Belgian firm could do without. UCB released only a top-down look at its third-quarter financial performance, but even this revealed a downturn in revenues, prompted by currency effects and generic competition to top-selling products (see Belgium: 31 October 2008: UCB Confirms Full-Year Outlook Despite Continued Sales Dip in Q3). As it stands, full-year gains in profitability will be generated mainly by a group-restructuring programme, rather than dynamic growth in turnover (see Belgium: 28 August 2008: UCB Unveils SHAPE Restructuring Programme, Prepares to Downsize 17% of Staff).
Regarding Cimzia, the drug's U.S. approval in Crohn's disease last April has given UCB access to a therapeutic market area valued at over US$1 billion, with the United States accounting for more than 70% of the global Crohn's disease market. Despite heavy competition in this area from the likes of Abbott Laboratories' (U.S.) Humira (adalimumab), Schering-Plough's (U.S.) Remicade (infliximab), and Biogen Idec's (U.S.) Tysabri (natalizumab), Cimzia's sales should grow steadily in this indication, ensuring a steady stream of revenue for UCB. The FDA's Complete Response Letter did not raise any efficacy issues for Cimzia, and the clinical trials used to support the drug's BLA make a clear case for the drug's effectiveness in reducing the progression of joint damage in rheumatoid arthritis patients, compared with placebo. This suggests that the EMEA is also unlikely to raise questions over efficacy, although whether it will follow the FDA's tough stance on product safety remains to be seen.