Cimzia®, the only PEGylated anti-TNF, approved in Europe and
available in a syringe designed in part
(Thomson Reuters ONE) - * Cimzia® (certolizumab pegol), in combination with methotrexate (MTX), approved by the European Commission for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients inadequately responsive to disease-modifying antirheumatic drugs (DMARDs) including MTX * Cimzia® can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate * Cimzia® has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with MTX.Brussels, BELGIUM, 5 October, 2009 - 15:30 (CEST) - regulatedinformation - UCB announced today that the European Commission (EC)approved Cimzia®, in combination with MTX, for the treatment ofmoderate to severe active RA in adult patients inadequatelyresponsive to disease-modifying antirheumatic drugs (DMARDs)including MTX. Cimzia® can be given as monotherapy in case ofintolerance to MTX or when continued treatment with MTX isinappropriate.Cimzia® has been approved to be administered as a subcutaneousinjection using the new prefilled syringe designed in partnershipwith OXO Good Grips®, a brand dedicated to providing innovativeconsumer products that make everyday living easier. The UCB and OXOGood Grips® partnership resulted in a redesign of the traditionalsyringe with the aim of making self-administration easy for peopleliving with RA. The syringe is designed for use by patients withdifferent grip styles and strengths and it provides measurableimprovements in the patient experience."Cimzia® has been shown to rapidly reduce the rate of progression ofjoint damage and to improve measurements of patients' physicalfunction," said Dr Prof. Dr. Iris Loew-Friedrich, Chief MedicalOfficer of UCB. "These are areas of a key concern for rheumatologistswhen treating patients with active RA, and we therefore believeCimzia® provides an important new treatment option."In the RAPID 1 and RAPID 2 clinical trials statisticallysignificantly greater ACR20 and ACR50 responses were achieved fromWeek 1 and Week 2, respectively, in both clinical trials compared toplacebo. Responses were maintained through Weeks 52 (RAPID 1) and 24(RAPID 2). Additionally, the RAPID 1 open label extension study, inpatients who responded to treatment with Cimzia®, showed that theimprovements gained in ACR20/50/70 scores were sustained for twoyears in patients receiving Cimzia®, in combination with MTX.Radiographic data showed inhibition of the progression of structuraljoint damage, was observed at 24 weeks of treatment, in RA patientstreated with Cimzia® in combination with MTX and sustained for 100weeks (100 week data are results from the open-label extension studyof RAPID 1).The recommended starting dose of Cimzia® for adult patients with RAis 400mg (as 2 injections of 200mg each on one day) at weeks 0, 2 and4, followed by a maintenance dose of 200mg every 2 weeks. MTX shouldbe continued during treatment with Cimzia where appropriate.The European approval is supported by data from a comprehensiveclinical development programme, involving more than 2,300 patientswith RA and over 4,000 patient-years experience.As observed with other anti-TNF's in the pivotal clinical trialsreported serious adverse reactions included infections (includingtuberculosis) and malignancies (including lymphoma). The most commonadverse reactions belonged to the system organ classes Infections andInfestations, reported in 15.5% of patients on Cimzia® and 7.6% ofpatients on placebo, and General disorders and administration siteconditions, reported in 10.0% of patients on Cimzia® and 9.7% ofpatients on placebo. A pooled analysis of the safety data showedthere was a low incidence of injection site pain (1.5%) and a lowlevel of discontinuations due to adverse events (5%). Cimzia®demonstrated a favorable risk-benefit profile in patients with atleast up to two years of drug exposure.The U.S. Food and Drug Administration (FDA) recently approvedCimzia®, together with MTX, for the treatment of adult patients withmoderately to severely active RA.For further informationScott Fleming, Global Communications Manager - ImmunologyT +44.770.277.7378, scott.fleming(at)ucb.comRichard Simpson, Investor Relations, UCBT +32.2.559.9494, richard.simpson(at)ucb.comMichael Tuck-Sherman, Investor Relations, UCBT +32.2.559.9712, michael.tuck-sherman(at)ucb.comNancy Nackaerts, External Communications, UCBM: +32 473 86 44 14, nancy.nackaerts(at)ucb.comGretchen Holt, Corporate Communications Manager OXOT +1212 242 3333, gholt(at)oxo.comNotes To EditorsAbout Cimzia®Cimzia® is the only PEGylated anti-TNF (Tumor Necrosis Factor).Cimzia® has a high affinity for human TNF-alpha, selectivelyneutralizing the pathophysiological effects of TNF-alpha. Over thepast decade, TNF-alpha has emerged as a major target of basicresearch and clinical investigation. This cytokine plays a key rolein mediating pathological inflammation, and excess TNF-alphaproduction has been directly implicated in a wide variety ofdiseases. The U.S. Food and Drug Administration (FDA) has approvedCimzia® for reducing signs and symptoms of Crohn's disease andmaintaining clinical response in adult patients with moderately toseverely active disease who have had an inadequate response toconventional therapy and for the treatment of adults with moderatelyto severely active rheumatoid arthritis. Cimzia® was approved inSwitzerland for induction of a clinical response and for themaintenance of a clinical response and a remission in patients withactive Crohn's disease who have not responded adequately toconventional treatment in September 2007. UCB is also developingCimzia® in other autoimmune disease indications. Cimzia® is aregistered trademark of UCB PHARMA S.A.OXO® and GOOD GRIPS® are trademarks of Helen of Troy Limited (NASDAQHELE) and are used under license.About RAPID 1The Phase III double-blind placebo-controlled trial, involving 982adults, was designed to establish the efficacy and tolerability ofcertolizumab pegol together with MTX, in the treatment of active RAin patients who did not adequately respond to conventional treatment.Patients were randomly allocated to receive one of three treatmentregimens: 393 patients received certolizumab pegol 400 mg and atWeeks 0, 2 and 4, then 200 mg every two weeks; 390 patients receivedcertolizumab pegol 400 mg every 2 weeks; 199 patients receivedplacebo every 2 weeks. RAPID 1 met co-primary endpoints: ACR20response rate at Week 24 and change from baseline in mTSS at Week 52.About RAPID 2This Phase III double-blind placebo-controlled trial, involving 619patients with active adult-onset RA was designed to evaluate theefficacy and tolerability of subcutaneous (SC) liquid certolizumabpegol (200 and 400 mg) together with MTX every 2 weeks compared toplacebo together with MTX in patients with active RA despite >= 6months treatment with MTX. Patients were randomly allocated toreceive one of three treatment regimens: 246 patients receivedcertolizumab pegol (liquid formulation) 400 mg and at Weeks 0, 2 and4, then 200 mg every two weeks; 246 patients received certolizumabpegol (liquid formulation) 400 mg every 2 weeks; 127 patientsreceived placebo every 2 weeks. RAPID 2 met its primary endpointACR20 response rate at Week 24, and secondary endpoints: change frombaseline in mTSS, ACR 50 and ACR 70 responses at Week 24.Significantly more patients in the certolizumab pegol 200 and 400 mggroups achieved an ACR20 response versus placebo (p<= 0.001); rateswere 57.3%, 57.6%, and 8.7%, respectively. Certolizumab pegol 200 and400 mg also significantly inhibited radiographic progression; meanchanges from baseline in mTSS at Week 24 were 0.2 and -0.4,respectively, versus 1.2 for placebo (rank analysis p<= 0.01).Certolizumab pegol treated patients reported rapid and significantimprovements in physical function versus placebo (p<= 0.001).Important safety informationThe most common adverse reactions belonged to the system organclasses Infections and infestations, reported in 15.5% of patients onCimzia and 7.6% of patients on placebo, and General disorders andadministration site conditions, reported in 10.0% of patients onCimzia and 9.7% of patients on placebo.The most serious adversereactions were serious infections (including tuberculosis andhistoplasmosis), malignancies (including lymphoma) and heart failure.A pooled analysis of the safety data show there was a low incidenceof injection site pain (1.5 percent) and low level ofdiscontinuations due to adverse events.Cimzia® is contraindicated in patients with active tuberculosis orother severe infections such as sepsis, abscesses and opportunisticinfections and in patients with moderate to severe heart failure.Before initiation of Cimzia®, evaluate patients for both active orinactive (latent) tuberculosis infection. Monitor patients for thedevelopment of signs and symptoms of infection during and aftertreatment with Cimzia®. If an infection develops, monitor carefully,and stop Cimzia® if infection becomes serious.Use of TNF blockers, including Cimzia®, may increase the risk ofreactivation of hepatitis B virus (HBV) in patients who are chroniccarriers of this virus, of new onset or exacerbation of clinicalsymptoms and/or radiographic evidence of demyelinating disease, inthe formation of autoantibodies and uncommonly in the development ofa lupus-like syndrome or of severe hypersensitivity reactionsfollowing Cimzia administration. If a patient develops any of theseadverse reactions, Cimzia® should be discontinued and appropriatetherapy instituted.Adverse reactions of the hematologic system, including medicallysignificant cytopenia, have been infrequently reported with Cimzia®.Advise all patients to seek immediate medical attention if theydevelop signs and symptoms suggestive of blood dyscrasias orinfection (e.g., persistent fever, bruising, bleeding, pallor) whileon Cimzia®. Consider discontinuation of Cimzia® therapy in patientswith confirmed significant haematological abnormalities.The use of Cimzia® in combination with biological DMARDS such asanakinra, abatacept and rituximab is not recommended due to apotential increased risk of serious infections. As no data areavailable, Cimzia® should not be administered concurrently with livevaccines or attenuated vaccines.Please see full prescribing information before prescribing.About UCBUCB, Brussels, Belgium (www.ucb.com) is a biopharmaceutical companydedicated to the research, development and commercialization ofinnovative medicines with a focus on the fields of central nervoussystem and immunology disorders. Employing approximately 10,000people in over 40 countries, UCB generated revenue of EUR 3.6 billionin 2008. UCB is listed on Euronext Brussels (symbol: UCB).About OXOFounded in 1990 on the concept of Universal Design, OXO's mission isto create consumer household products that ease the tasks of everydaylife for the widest range of users possible. Since the original 15items were introduced, the OXO collection has grown to more than 800strong covering areas for cooking, cleaning, gardening, storing,organizing and lighting. Today OXO Good Grips products are sold in 54countries and are included in the permanent collections of numerousmuseums. The company has won more than 100 design and business awardsworldwide. OXO is very frequently used as a case study on how awell-executed Universal Design philosophy can be a successfulbusiness strategy. OXO is owned by Helen of Troy Limited, a leadingdesigner, producer and global marketer of brand-name personal careand household consumer products.Forward-looking statementsThis press release contains forward-looking statements based oncurrent plans, estimates and beliefs of management. Such statementsare subject to risks and uncertainties that may cause actual resultsto be materially different from those that may be implied by suchforward-looking statements contained in this press release. Importantfactors that could result in such differences include: changes ingeneral economic, business and competitive conditions, effects offuture judicial decisions, changes in regulation, exchange ratefluctuations and hiring and retention of its employees.For the pdf-version of this press release, please click on the linkbelow:http://hugin.info/133973/R/1345745/323100.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 05.10.2009 - 15:37 Uhr
Sprache: Deutsch
News-ID 6573
Anzahl Zeichen: 0
contact information:
Town:
London
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 289 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Cimzia®, the only PEGylated anti-TNF, approved in Europe and
available in a syringe designed in part"
steht unter der journalistisch-redaktionellen Verantwortung von
UCB (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
