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UCB (EBR:UCB) UCB Media Room: ava Connect®

Directive transparence : information réglementée

19/03/2021 07:04
https://mb.cision.com/Public/18595/3309578/b994f540ea69c96c_800x800ar.jpg ** UCB Gains CE Mark for ava Connect^=C2=AE, a first-in-class electromechan= ical device for use with biologic treatment in rheumatology and dermatology ------------------------------------------------------------ ava Connect^=C2=AE is designed to help improve the patient experience and m= edication adherence for CIMZIA^=C2=AE (certolizumab pegol) by providing a c= omfortable injection and recording the patient=E2=80=99s injection administ= ration, visualized on the CimplyMe^=C2=AE companion app Brussels, Belgium =E2=80=93 March 19, 2021 =E2=80=93 UCB, a global biopharm= aceutical company, today announced that its first-in-class electromechanica= l injection device, ava Connect^=C2=AE, has received its Declaration of Con= formity (CE) Mark.^1=C2=A0The CE Mark indicates conformity with health, saf= ety, and environmental protection standards for products sold within the Eu= ropean Economic Area (EEA).^2=C2=A0 The ava Connect^=C2=AE and disposable dose-dispenser cartridge are used for= self-injecting CIMZIA^=C2=AE (certolizumab pegol), an anti-TNF therapy use= d to treat adults with rheumatoid arthritis, axial spondyloarthritis, psori= atic arthritis, and psoriasis (see About CIMZIA section below for complete = indication information). It is the first reusable device of its kind availa= ble for use with biologic treatment in rheumatology and dermatology in Euro= pe.^3=C2=A0To accompany ava Connect^=C2=AE and further support patients, UC= B has also developed CimplyMe^=C2=AE, a companion mobile application. Both = are part of UCB=E2=80=99s mission to transform the way patient support is d= elivered and accelerate better outcomes for people living with severe disea= ses as part of its digital business transformation. =E2=80=9CAt UCB, we are increasing our ability to provide differentiating p= atient value with advanced technology solutions. With the recent accelerati= on of telemedicine, ava Connect^=C2=AE and CimplyMe^=C2=AE can help improve= the patient experience and help to make it easier to connect with healthca= re providers outside of face-to-face consultations by providing symptom and= treatment adherence monitoring reports. With these technological innovatio= ns, UCB aims to be a pioneer in digital medicine for rheumatology and derma= tology patients,=E2=80=9D said Emmanuel Caeymaex, Executive Vice President,= Immunology Solutions and Head of US, UCB.=C2=A0 The ava Connect^=C2=AE e-device has been developed together with patients t= o address injection and treatment management challenges that can lead to lo= w persistency.^4,5=C2=A0Up to 68 percent of self-injecting patients are non= -compliant at one year of treatment, resulting in increased healthcare reso= urce utilization (e.g. hospitalizations, inpatient visits, treatment cost, = etc.) due to suboptimal treatment outcomes.^6=C2=A0This observation is base= d on 19 studies reporting compliance data covering rheumatoid arthritis and= Crohn=E2=80=99s disease patients treated with infliximab, adalimumab, goli= mumab and etanercept. The device has a hidden needle and non-slip hand grip to assist patients wi= th dexterity issues. The large start/pause button and injection speed choic= e give patients control over their injections. The information screen allow= s patients to access step-by-step instructions, confirms injection completi= on and provides injection date notifications.^7=C2=A0Studies have demonstra= ted that patients find the e-device easy to use and are satisfied with thei= r self-injection experience.^8 The ava Connect^=C2=AE e-device also logs injection dates, allowing it to r= ecord objectively patient adherence, which can be shared with clinicians. S= kin sensors automatically stop an injection if skin contact is lost and the= needle is retracted within the device. After re-positioning, the injection= can continue, preventing medication waste and helping to ensure the patien= t receives the full dose. Safety features ensure that the medication cartri= dge is automatically checked for drug identity, expiry status, and use stat= us before an injection is given.^7=C2=A0 CimplyMe^=C2=AE, the companion mobile application for ava Connect^=C2=AE, e= nables a treatment experience for patients that takes a holistic approach t= o chronic disease management. By using CimplyMe^=C2=AE with ava Connect^=C2= =AE, patients will be able to access their injection data, disease manageme= nt and treatment information, and track and monitor their disease symptoms,= as well as receive injection reminders. The ava Connect^=C2=AE device can = be paired with CimplyMe^=C2=AE via a smartphone Bluetooth. CimplyMe^=C2=AE can create reports that patients can share with their healt= hcare providers, aiming to support patients to have more efficient consulta= tions and informed treatment decisions with their healthcare providers guid= ed by the health metrics and objective injection log.=C2=A0 The ava Connect^=C2=AE e-device is part of a portfolio of CIMZIA self-injec= tion devices that includes the CIMZIA^=C2=AE pre-filled syringe and the Aut= oClicks^=C2=AE pre-filled pen. The portfolio aims to provide to HCPs and pa= tients the choice to identify together the right device for the unmet patie= nt needs and hence to help improve patient self-injection experience, help = increase adherence and potentially improve clinical outcomes. UCB continued= its partnership with OXO, a company known for thoughtful, consumer friendl= y designs, to develop the ava Connect^=C2=AE e-device. About OXO Founded in 1990 on the concept of inclusive universal design, OXO creates h= ousehold products that make everyday task and chores better. The OXO portfo= lio spans several categories: cooking, baking, cleaning, storage and organi= zation, coffee and baby. OXO is available in 90 countries worldwide; its ic= onic products are included in the permanent collections of numerous museums= , including the Museum of Modern Art and the Smithsonian Cooper Hewitt Nati= onal Design Museum. The brand has won over 100 design awards worldwide. OXO and Good Grips^=C2=AE are trademarks owned and/or licensed by Helen of = Troy Limited (NASDAQ, NM: HELE), and are used by UCB under license. About CIMZIA^=C2=AE in the EU/EEA In the EU, CIMZIA^=C2=AE in combination with methotrexate (MTX) is indicate= d for the treatment of moderate to severe active RA in adult patients inade= quately responsive to disease-modifying anti-rheumatic drugs (DMARDs) inclu= ding MTX.=C2=A0 CIMZIA can be given as monotherapy in case of intolerance to MTX or when co= ntinued treatment with MTX is inappropriate. CIMZIA in combination with MTX= is also indicated for the treatment of severe, active and progressive RA i= n adults not previously treated with MTX or other DMARDs. 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 combinati= on with MTX. CIMZIA, in combination with MTX, is also indicated for the treatment of act= ive psoriatic arthritis in adults when the response to previous DMARD thera= py has been inadequate. CIMZIA can be given as monotherapy in case of intol= erance to MTX or when continued treatment with MTX is inappropriate. CIMZIA is also indicated in the EU for the treatment of adult patients with= severe active axial spondyloarthritis (axSpA), comprising:=C2=A0 =C2=B7 Ankylosing spondylitis (AS) =E2=80=93 adults with severe active AS w= ho have had an inadequate response to, or are intolerant to non-steroidal a= nti-inflammatory drugs (NSAIDs).=C2=A0 =C2=B7 Axial spondyloarthritis (axSpA) without radiographic evidence of AS = =E2=80=93 adults with severe active axSpA without radiographic evidence of = AS but with objective signs of inflammation by elevated C-reactive protein = (CRP) and/or Magnetic Resonance Imaging (MRI) who have had an inadequate re= sponse to or are intolerant to NSAIDs. CIMZIA is also indicated for the treatment of moderate to severe plaque pso= riasis in adults who are candidates for systemic therapy.=C2=A0 Cimzia^=C2=AE (certolizumab pegol) EU/EEA* Important Safety Information=C2= =A0 Date of revision March 2021 Cimzia^=C2=AE was studied in 4,049 patients with rheumatoid arthritis (RA) = in controlled and open label trials for up to 92 months. The commonly repor= ted adverse reactions (1-10%) in clinical trials with Cimzia^=C2=AE and pos= t-marketing were viral infections (includes herpes zoster, papillomavirus, = influenza), bacterial infections (including abscess), rash, headache (inclu= ding migraine), asthenia, leukopenia (including lymphopenia, neutropenia), = eosinophilic disorder, pain (any sites), pyrexia, sensory abnormalities, hy= pertension, pruritus (any sites), hepatitis (including hepatic enzyme incre= ase), injection site reactions, and nausea. Serious adverse reactions inclu= de sepsis, opportunistic infections, tuberculosis (including miliary, disse= minated and extrapulmonary), herpes zoster, lymphoma, leukaemia, solid orga= n tumours, angioneurotic oedema, cardiomyopathies (includes heart failure),= ischemic coronary artery disorders, pancytopenia, hypercoagulation (includ= ing thrombophlebitis, pulmonary embolism), cerebrovascular accident, vascul= itis, hepatitis/hepatopathy (includes cirrhosis), and renal impairment/neph= ropathy (includes nephritis). In RA controlled clinical trials, 4.4% of pat= ients discontinued taking Cimzia=C2=AE due to adverse events vs. 2.7% for p= lacebo.=C2=A0 Cimzia was initially studied in 325 patients with active axial spondyloarth= ritis (including ankylosing spondylitis and non-radiographic axial spondylo= arthritis) in the AS001 clinical study for up to 4 years, which includes a = 24-week placebo-controlled phase followed by a 24-week dose-blind period an= d a 156-week open-label treatment period. Cimzia was subsequently studied i= n 317 patients with non-radiographic axial spondyloarthritis in a placebo-c= ontrolled study for 52 weeks (AS0006). Cimzia was also studied in patients = with axial spondyloarthritis (including ankylosing spondylitis and non-radi= ographic axial spondyloarthritis) in a clinical study for up to 96 weeks, w= hich included a 48-week open-label run-in phase (N=3D736) followed by a 48-= week placebo-controlled phase (N=3D313) for patients in sustained remission= (C-OPTIMISE). In all 3 studies, the safety profile for these patients was = consistent with the safety profile in rheumatoid arthritis and previous exp= erience with Cimzia.=C2=A0 Cimzia=C2=AE was studied in 409 patients with psoriatic arthritis (PsA) in = a clinical study for up to 4 years which included a 24-week placebo-control= led phase followed by a 24-week dose-blind period and a 168-week open-label= treatment period.=C2=A0 The safety profile for axSpA and PsA patients treated with Cimzia^=C2=AE wa= s consistent with the safety profile in RA and previous experience with Cim= zia=C2=AE.=C2=A0 Cimzia^=C2=AE was studied in 1112 patients with psoriasis in controlled and= open-label studies for up to 3 years. In the Phase III program, the initia= l and maintenance periods were followed by a 96-week open-label treatment p= eriod. The long-term safety profile of Cimzia=C2=AE 400 mg every 2 weeks an= d Cimzia^=C2=AE 200 mg every 2 weeks was generally similar and consistent w= ith previous experience with Cimzia.=C2=A0 *EU/EEA means European Union/European Economic Area Cimzia^=C2=AE is contraindicated in patients with hypersensitivity to the a= ctive substance or any of the excipients, active tuberculosis or other seve= re infections such as sepsis or opportunistic infections, and moderate to s= evere heart failure.=C2=A0Serious infections including sepsis, tuberculosis= and opportunistic infections (e.g. histoplasmosis, nocardia, candidiasis) = have been reported in patients receiving Cimzia^=C2=AE. Some of these event= s have been fatal. Before initiation of therapy with Cimzia^=C2=AE, all pat= ients must be evaluated for both active and inactive (latent) tuberculosis = infection. If active tuberculosis is diagnosed prior to or during treatment= , Cimzia^=C2=AE therapy must not be initiated and must be discontinued. If = latent tuberculosis is diagnosed, appropriate anti- tuberculosis therapy mu= st be started before initiating treatment with Cimzia^=C2=AE.=C2=A0 Reactivation of hepatitis B has occurred in patients receiving a TNF-antago= nist including Cimzia^=C2=AE who are chronic carriers of the virus (i.e. su= rface antigen positive). Some cases have had a fatal outcome. Patients shou= ld be tested for HBV infection before initiating treatment with Cimzia^=C2= =AE. Carriers of HBV who require treatment with Cimzia^=C2=AE should be clo= sely monitored and in the case of HBV reactivation Cimzia^=C2=AE should be = stopped and effective anti-viral therapy with appropriate supportive treatm= ent should be initiated.=C2=A0 TNF antagonists including Cimzia^=C2=AE may increase the risk of new onset = or exacerbation of clinical symptoms and/or radiographic evidence of demyel= inating disease including multiple sclerosis; of formation of autoantibodie= s and uncommonly of the development of a lupus-like syndrome; of severe hyp= ersensitivity reactions. If a patient develops any of these adverse reactio= ns, Cimzia^=C2=AE should be discontinued and appropriate therapy instituted= .=C2=A0 With the current knowledge, a possible risk for the development of lymphoma= s, leukaemia or other malignancies in patients treated with a TNF antagonis= t cannot be excluded. Rare cases of neurological disorders, including seizu= re disorder, neuritis and peripheral neuropathy, have been reported in pati= ents treated with Cimzia^=C2=AE.=C2=A0 Adverse reactions of the haematologic system, including medically significa= nt cytopenia, have been reported with Cimzia=C2=AE. Advise all patients to = seek immediate medical attention if they develop signs and symptoms suggest= ive of blood dyscrasias or infection (e.g., persistent fever, bruising, ble= eding, pallor) while on Cimzia^=C2=AE. Consider discontinuation of Cimzia^= =C2=AE therapy in patients with confirmed significant haematological abnorm= alities.=C2=A0 The use of Cimzia^=C2=AE in combination with anakinra or abatacept is not r= ecommended due to a potential increased risk of serious infections. As no d= ata are available, Cimzia=C2=AE should not be administered concurrently wit= h live vaccines. The 14-day half-life of Cimzia^=C2=AE should be taken into= consideration if a surgical procedure is planned. A patient who requires s= urgery while on Cimzia=C2=AE should be closely monitored for infections.=C2= =A0 Please consult the full prescribing information in relation to other side e= ffects, full safety and prescribing information.=C2=A0European SmPC date of= revision March 2021.=C2=A0 https://www.ema.europa.eu/en/documents/product-information/cimzia-epar-prod= uct-information_en.pdf Last accessed: March 2021. References: 1. UCB Pharma Data on File. ava Connect CE Declaration of Conformity. Febru= ary 2021. 2. European Commission. CE marking. Available from: https://ec.europa.eu/gr= owth/single-market/ce-marking_en. Last accessed: January 2021. 3. UCB Pharma Data on File. CIMZIA^=C2=AE AutoClicks^=C2=AE =E2=80=93 Pre-F= illed Pen Comparison. January 2021. 4. van den Bemt B, Gettings L, Doma=C5=84ska B, et al. A portfolio of biolo= gic self-injection devices in rheumatology: how patient involvement in devi= ce design can improve treatment experience. Drug deliv. 2019;26(1):384=E2= =80=93392.=C2=A0 5. Doma=C5=84ska B, Stumpp O, Poon S, et al. Using Patient Feedback to Opti= mize the Design of a Certolizumab Pegol Electromechanical Self-Injection De= vice: Insights from Human Factors Studies. Adv Ther. 2018;35(1):100-115. 6. Maniadakis N, Toth E, Schiff M, et al. A Targeted Literature Review Exam= ining Biologic Therapy Compliance and Persistence in Chronic Inflammatory D= iseases to Identify the Associated Unmet Needs, Driving Factors, and Conseq= uences. Adv Ther. 2018;35(9):1333=E2=80=931355. 7. UCB Pharma Data on File. Cimzia=C2=AE ava=C2=AE BLE - User Manual - UK M= arket. July 2020. 8. Pouls B, Kristensen L, Petersson M, et al. A pilot study examining patie= nt preference and satisfaction for ava^=C2=AE, a reusable electronic inject= ion device to administer certolizumab pegol. Expert Opin Drug Deliv. 2020;1= 7(5):705-711. GenericFile ava CE Mark Press Release FINAL FOR DISTRIBUTION (https://mb.cision.com/Pub= lic/18595/3309578/9f824e6514d6f16e.pdf)=0D =0D ______________________=0D If you would rather not receive future communications from UCB SA, please g= o to https://eu.vocuspr.com/OptOut.aspx?2973226x20421x64481x1x6868579x24000= x6&Email=3Dregnews%40symexglobal.com.=0D UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . B - 1070 Belgium=