UCB's CIMZIA(R) (certolizumab pegol) Approved by the U.S. FDA for Adult Patients Suffering From Moderate to Severe Rheumatoid Arthritis

/PRNewswire/ UCB announced today that the U.S. Food and Drug Administration (FDA) approved Cimzia(R), the only PEGylated anti-TNF (Tumor Necrosis Factor), for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). Cimzia(R) can be dosed at 400 mg initially and at weeks two and four, followed by 200 mg every other week; for maintenance dosing, 400 mg every four weeks can be considered.

In clinical trials with Cimzia(R), together with methotrexate (MTX), patients experienced a significant reduction in the signs and symptoms of RA at week 24 with some showing clinical responses within one to two weeks, compared with MTX alone. Additionally, radiographic data showed Cimzia(R), together with MTX, inhibited progression of joint damage, with a significantly smaller change from baseline in modified Total Sharp Score (TSS) at 24 and 52 weeks of treatment, compared with MTX alone (p<0.001).

"The approval of Cimzia(R) for moderate to severe rheumatoid arthritis in the U.S. is a major milestone for UCB, and most importantly, for people seeking a new treatment option to manage this debilitating condition," said Roch Doliveux, Chief Executive Officer of UCB. "UCB is committed to developing new therapies, such as Cimzia(R), to help meet the needs of patients living with rheumatoid arthritis and other immune diseases. I am also proud of our partnership with OXO(R) and of the fact that RA patients were directly involved in the design and development of our new prefilled syringe, which is designed to make self-administration easy for people living with rheumatoid arthritis."

The new prefilled Cimzia(R) syringe is now also available for subcutaneous self-administration to U.S. patients with moderate to severe Crohn's disease who have had an inadequate response to conventional therapy.

The FDA approval is based on UCB's comprehensive clinical program, including data from four multi-center placebo-controlled phase III trials, involving more than 2 300 patients with RA and over 4 000 patient-years experience. Cimzia(R) has been studied at dosing intervals of two or four weeks, and administered together with MTX or as monotherapy.

In the pivotal clinical trials, reported serious adverse reactions were infections including tuberculosis and malignancies including lymphoma. The most commonly occurring adverse events were upper respiratory tract infections, rash and urinary tract infections. A pooled analysis of the safety data show there was a low incidence of injection site pain (<2%) and a low level of discontinuations due to adverse events (5%).

"People with RA have pain and swelling of joints with stiffness and fatigue which makes it difficult for them to perform many activities of daily living, sometimes making it a struggle to even get out of bed," said Roy Fleischmann, MD, Clinical Professor in the Department of Internal Medicine at the University of Texas Southwestern Medical Center in Dallas. "With the approval of Cimzia(R), I now have another alternative to offer my patients in an easy-to-use treatment that improves quality of life and inhibits structural damage."

It is estimated that 5 million people suffer from RA globally. In the United States alone, an estimated 1.3 million people have the disease. Prevalence is not split evenly between genders, since women are three times more likely to be affected than men. Although RA can affect people of all ages, the onset of the disease usually occurs between 35-55 years of age.

Forward-looking statements

This press release contains forward-looking statements based on current plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuations and hiring and retention of its employees.

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