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Clinical Profiles
EMPAGLIFLOZIN (JARDIANCE®) APPROVED IN IRELAND FOR THE TREATMENT OF HEART FAILURE WITH REDUCED EJECTION FRACTION The European Commission has granted marketing authorisation for Empagliflozin (Jardiance®) as a treatment for adults with symptomatic chronic heart failure with reduced ejection fraction (systolic heart failure) in Ireland, Boehringer Ingelheim and Eli Lilly and Company have announced. The extension of the indication follows a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) on 20 May 2021. Marketing authorisation is based on results from the EMPEROR-Reduced trial in which empagliflozin showed a significant 25 percent reduction (ARR 5.2%) in the combined relative risk versus placebo of cardiovascular death or hospitalisation due to heart failure. The findings from the primary endpoint were consistent in subgroups with or without type 2 diabetes. Key secondary endpoint analyses from the trial demonstrated that empagliflozin reduced the relative risk of first and recurrent hospitalisation for heart failure by 30 percent (ARR 8.7%) and significantly slowed kidney function decline. “Empagliflozin was the first SGLT2 inhibitor to demonstrate cardiovascular protective effects and improve cardiovascular outcomes in patients with type 2 diabetes,” said Dr Douglas Clark, Head of Medical Affairs for UK and Ireland at Boehringer Ingelheim. “We are delighted to now be able to offer empagliflozin to people with heart failure with reduced ejection fraction, regardless of diabetes status, and to provide an additional treatment option for the thousands of people who live with heart failure and important metabolic conditions. We look forward to collaborating with NCPE to ensure access to this trusted therapy.” Heart failure is often associated with other diseases of the cardiorenal-metabolic systems such as type 2 diabetes and kidney disease. Due to the interconnected nature of these systems, improvement in one system can lead to positive effects throughout the others. Heart failure is a very common and severe complication of a heart attack and occurs when the heart cannot pump sufficient blood to the rest of the body.[iv],[v] There are two forms of the condition; heart failure with reduced ejection fraction means the heart cannot contract normally, while preserved ejection
fraction means the heart cannot properly fill with blood. People with heart failure often experience breathlessness and fatigue, which can severely impact their quality of life. The EMPEROR-Reduced trial is part of the EMPOWER clinical programme, exploring the impact of empagliflozin on the lives of people across the spectrum of cardio-renal-metabolic conditions. The safety profile was similar to the established safety profile of empagliflozin. DUPIXENT® (DUPILUMAB) SMPC UPDATED WITH LONGTERM DATA REINFORCING WELL-ESTABLISHED SAFETY PROFILE IN ADULTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS Long-term safety data from a study of adults with moderate-tosevere atopic dermatitis treated with Dupixent will be added to the Dupixent Summary of Product Characteristics (SmPC) following a positive opinion issued by the European Medicines Agency's Committee for Medicinal Products for Human Use. Data from a single-arm Phase 3 open label extension (OLE) trial showed the long-term safety profile in adults with moderate-tosevere atopic dermatitis treated with Dupixent and observed up to three years was generally consistent with what was observed in the controlled pivotal Phase 3 trials. The OLE trial assessed the long-term safety of Dupixent 300 mg weekly in adults who had previously participated in Dupixent trials or had been screened for a Phase 3 trial. The approved Dupixent dose in adults is 300 mg every other week. Atopic dermatitis is a chronic inflammatory disease of the skin that can be debilitating. Moderate-to-severe atopic dermatitis is characterized by intense persistent itch and skin lesions that can cover much of the body, resulting in skin dryness, cracking, redness or darkening, crusting and oozing. Itch is one of the most burdensome symptoms for patients. Moderate-to-severe atopic dermatitis can also have a substantial emotional and psychosocial impact on patients and their families, causing sleep disturbance, anxiety, depression and feelings of isolation. Dupixent is the only biologic approved in the EU for children as young as six with severe atopic dermatitis and for adolescents and adults with moderate-tosevere atopic dermatitis who are candidates for systemic therapy.
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Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins. IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP) and eosinophilic esophagitis (EoE). Dupixent is not an immunosuppressant and does not require ongoing lab monitoring. Dupixent is currently approved in more than 60 countries, and more than 260,000 patients have been treated globally. HSE REIMBURSES NEW SUBCUTANEOUS FORMULATION OF TYSABRITM (NATALIZUMAB) TO TREAT ADULTS LIVING WITH HIGHLY ACTIVE RELAPSING REMITTING-MULTIPLE SCLEROSIS Biogen Ireland have announced that the HSE has agreed to reimburse a subcutaneous (SC) injection of TYSABRITM (natalizumab) for adults living with highly active relapsing-remitting multiple sclerosis (MS). The announcement follows the European Commission’s (EC) decision on the 30th March 2021 meaning that the new route of administration is now approved in Ireland. Natalizumab SC offers comparable efficacy and safety and builds on the long-term data and established clinical benefits of the natalizumab intravenous (IV) formulation. Natalizumab is the only high-efficacy disease modifying therapy for RRMS that offers two routes of administration providing patients and healthcare professionals (HCPs) with the flexibility to choose the one that best fits their individual needs. The SC and IV formulations of natalizumab 300 mg, are administered once every four weeks by a HCP in a clinical setting. The new SC formulation expands the clinical setting beyond infusion centres, potentially bringing care closer to home, e.g., via community healthcare centres, offering patients treatment convenience whilst still providing medical oversight of treatment administration. The administration by a HCP allows for ongoing disease monitoring, including screening for progressive multifocal leukoencephalopathy (PML), identifying and treating potential hypersensitivity reactions and
ensuring adherence to treatment. As well as the shorter SC administration time, compared to the IV formulation, the SC injections also provide the option for HCPs to reduce or remove the 1-hour post-dose observation period, after the first six doses, based on clinical judgement. “This is an important treatment option for people living with MS, as it provides individuals with more flexibility around how they would like to receive their treatment. It still provides people with the opportunity to access their MS Care team but will minimise the time spent receiving treatment and can potentially be administered in more convenient locations, closer to home” said Ava Battles, CEO, MS Ireland. The approval of the SC route of administration for natalizumab is based on data from the DELIVER (Phase 1) and REFINE (Phase 2) studies. The SC formulation of natalizumab 300 mg has shown comparability to the Q4W IV administration of 300mg natalizumab in efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) profiles. The safety of natalizumab SC in both the DELIVER and REFINE studies was generally consistent with the well-established benefitrisk profile of natalizumab IV in other clinical studies and the post-marketing setting, with the exception of injection site pain which can occur with SC injections. “This unprecedented year has put the HSE under significant resource pressures and created new challenges for those living with long-term conditions, like MS, when accessing vital, life impacting treatments,” said Dr Bronagh Hayden, Head of Medical Affairs Biogen Ireland. “As our healthcare and everyday environment evolves, we must continue to provide solutions to address capacity and resource concerns within the health service, whilst addressing patient needs. Reinforced by nearly 15 years of real-world evidence and post marketing experience with natalizumab IV, SC offers a new method of delivery that can help to reduce patient time in a hospital setting and increase convenience in clinical practice.” LEO PHARMA ANNOUNCES MHRA AND EC APPROVAL OF ADTRALZA (TRALOKINUMAB)
LEO Pharma UK and Ireland, a leader in medical dermatology, has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) and the European
