Clinical Profiles

HEALTH AND SAFETY EXECUTIVE (HSE) APPROVES ADTRALZA ® �

LEO Pharma welcomes the news that the Health Service Executive (HSE) has approved tralokinumab for reimbursement in Ireland via the High-Tech Scheme. 3 This approval makes tralokinumab the first reimbursed biologic that specifically targets the IL-13 cytokine alone, a driver of atopic dermatitis signs and symptoms, for use within Ireland. 1,2,3

Tralokinumab is the first high affinity, human monoclonal antibody developed to specifically bind to and inhibit the IL-13 cytokine in adult patients with uncontrolled moderate-tosevere atopic dermatitis who are candidates for systemic therapy. 1,2 Tralokinumab is available in a 150 mg/mL prefilled syringe for subcutaneous injection with an initial dose of 600 mg followed by 300 mg every other week. 7 Tralokinumab can be used with or without topical corticosteroids (TCS). 7

“I am delighted that patients with moderate-to-severe Atopic Dermatitis in Ireland will now have access to tralokinumab, an important new treatment option for these patients. Atopic Dermatitis is much more than a skin condition, it can have a profound effect on the emotional and psychological wellbeing of patients, as well as on their physical health,” said Professor Alan Irvine, Consultant Dermatologist, School of Medicine Trinity College Dublin.

The evidence supporting the efficacy and safety of tralokinumab comes from four randomised, multicentre, doubleblind, placebo-controlled, phase III studies: ECZTRA 1, ECZTRA 2, ECZTRA 3 in patients with moderate-to-severe atopic dermatitis and ECZTRA 7 in patients with severe disease. 4,5,6

Tralokinumab was approved by the European Commission (EC) for adults with moderate-tosevere atopic dermatitis who are candidates for systemic therapy in Europe and by the Medicines & Healthcare products Regulatory Agency (MHRA) in Great Britain, in June 2021. The MHRA and EC decisions are valid in the UK and all European Union Member States, Iceland, Norway, and Liechtenstein. Tralokinumab is also approved for use in Canada, the United Arab Emirates and was approved by the U.S. Food and Drug Administration (FDA) on the 27th December 2021.

References on request

SPRAVATO ® � (ESKETAMINE) NASAL SPRAY APPROVED

The Janssen Pharmaceutical Companies of Johnson & Johnson has announced that SPRAVATO ® � (esketamine) nasal spray has been granted reimbursement in Ireland for the treatment of adults living with treatment-resistant major depressive disorder (TRD), in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI). People are considered to have TRD if they have not responded to at least two different treatments with antidepressants in the current moderate-to-severe depressive episode. 1

Ireland has one of the highest rates of mental illness in Europe and it is estimated that approximately 150,000 people per year are living with severe depression (also known as Major Depressive Disorder or MDD) here. 2,3 Major Depressive Disorder (MDD), the underlying disorder associated with Treatment Resistant Depression (TRD), is a severely debilitating psychiatric disorder. For these patients, the main goal of treatment is to relieve the symptoms of depression, and ultimately achieve remission, with few, if any, symptoms of depression remaining. 4 However, about one third of people with MDD do not respond to currently available treatments. 5

The approval of esketamine is based on data from a clinical trial programme in patients with TRD, including over 1,600 patients treated with esketamine. The five Phase 3 trials included three shortterm studies, one randomised withdrawal and maintenance of effect study, and one long-term safety study. 6,7,8,9,10* These data demonstrated that treatment with esketamine nasal spray plus a newly initiated oral antidepressant was associated with a greater reduction in depressive symptoms compared to a newly initiated oral antidepressant plus placebo nasal spray, in adult patients (18-64 years), with the onset of efficacy as early as Day 2. 6 Approximately 70 percent of esketamine-treated patients responded to treatment, with a ≥50 percent symptom reduction. Furthermore, approximately half of all treated patients achieved remission at the end of the 4 week studies. 1 Continued treatment with esketamine nasal spray plus oral antidepressant reduced the risk of relapse by 70 percent among patients with stable response and by 51 percent in patients in stable remission, compared to continuing treatment with oral antidepressant alone. 9

The decision to prescribe esketamine should be determined by a psychiatrist. 1 Esketamine is intended to be self-administered by the patient under the direct supervision of a healthcare professional. 1 A treatment session consists of nasal administration of esketamine and a postadministration observation period. Both administration and post -administration observation of esketamine should be carried out in the appropriate clinical setting. 1

Further prescribing information can be found at https://www. medicines.ie/medicines/ spravato-28-mg-nasal-spraysolution-35070/spc

References on request

BAYER’S NEW TREATMENT KERENDIA ® (FINERENONE) APPROVED IN EU

The European Commission has granted marketing authorization in the European Union (EU) for finerenone under the brand name Kerendia ® . Kerendia ® (10 mg or 20 mg), a non-steroidal, selective mineralocorticoid receptor antagonist, is indicated for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.

Finerenone is different to existing CKD in T2D treatments. It acts by blocking mineralocorticoid receptor (MR) overactivation, which is thought to contribute to CKD progression and cardiovascular damage.

“The worrying reality is that chronic kidney disease in type 2 diabetes is the leading cause of end-stage kidney disease, which ultimately means that the kidneys no longer support the body’s needs and patients need dialysis or a kidney transplant to stay alive. Early intervention is associated with a better prognosis, and it is key to prevent further end-organ damage by reducing the risk of kidney function loss,” said Dr. Michael Devoy, Chief Medical Officer and Head of Medical Affairs and Pharmacovigilance at Bayer’s Pharmaceuticals Division.“The approval of Kerendia offers physicians a new path to protect these vulnerable patients by reducing their risk of cardiovascular events and delaying kidney disease progression.”

The approval of Kerendia in the EU is based on the results of the pivotal Phase III FIDELIO- ACCORD HEALTHCARE LAUNCH ICATIBANT ACCORD 30 MG SOLUTION FOR INJECTION IN 3 ML PRE-FILLED SYRINGE

Accord Healthcare is delighted to announce the launch of another High-Tech medicine to their already extensive portfolio of High-Tech medicines: Icatibant Accord 30 mg which comes in a pack of one 3 ml pre-filled syringe.

This medicine is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older, with C1-esterase-inhibitor deficiency.

Please refer to the Summary of Product Characteristics (SPC) for further information. The SPC will be available from the launch date at www. hpra.ie and for Healthcare Professionals at www.accord-healthcare.ie.

Icatibant Accord will be available from both full-line wholesalers from launch. For further information please contact Accord in Cork on 021- 461 9040 or visit www.accord-healthcare.ie

Think High-Techs, Think Accord DKD study, presented at the American Society of Nephrology’s (ASN) Kidney Week 2020 and simultaneously published in the New England Journal of Medicine (NEJM) in October 2020.

In July 2021, Kerendia was approved by the U.S. Food and Drug Administration (FDA) based on the positive results of the FIDELIO-DKD Phase III study. In December 2021, Kerendia received a Grade A recommendation in the new treatment guidelines of the American Diabetes Association (ADA), “Standards of Medical Care in Diabetes 2022” for the treatment of patients with CKD and T2D who are at increased risk for cardiovascular events or CKD progression or are unable to use a sodium-glucose cotransporter 2 inhibitor.

Finerenone has also been submitted for marketing authorization in multiple other countries worldwide and these are currently under review.

LENALIDOMIDE CLONMEL

Clonmel Healthcare is delighted to announce the launch of Lenalidomide Clonmel 5mg, 10mg, 15mg, 20mg, 25mg hard capsules.

Lenalidomide Clonmel is indicated for the treatment of multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma and follicular lymphoma.

Lenalidomide is structurally related to thalidomide, which is a known human teratogen that causes severe life-threatening birth defects. An unborn child is likely to be harmed if exposed to lenalidomide during pregnancy, therefore a pregnancy prevention programme (PPP) is in place for all lenalidomide products and applies to all patients prescribed lenalidomide.

In order to support HCPs in fulfilling the requirements of the lenalidomide PPP, Clonmel Healthcare in collaboration with a number of other Marketing Authorisations Holders, has created an online platform called the Patient Safety Hub (PSH) which may be used by prescribers and pharmacies. It is available at www.patientsafetyhub.ie.

Pharmacies wishing to purchase and dispense Lenalidomide Clonmel must register via the Patient Safety Hub at www.patientsafetyhub.ie. Registration involves the pharmacy indicating its agreement and compliance with the requirements of the lenalidomide pregnancy prevention programme.

A user guide and training videos on use of the PSH are also available to access via the hub.

Full prescribing information is available on request or alternatively please go to www.clonmel-health.ie. Medicinal product subject to medical prescription.

Please contact Clonmel Healthcare on 01-6204000 if you require any additional information.

PA 126/320/002, 004-007. PA Holder: Clonmel Healthcare Ltd., Clonmel, Co. Tipperary. Date prepared: February 2022. 2022/ ADV/LEN/031H.

EC MSRKETING AUTHORISATION FOR JARDIANCE ®

Empagliflozin (Jardiance ® ) has been granted a marketing authorisation by the European Commission (EC) for the treatment of adults with symptomatic chronic heart failure. [i] With this latest approval, empagliflozin becomes the first and only clinically proven treatment that can significantly improve outcomes for adults across the full spectrum of symptomatic chronic heart failure, which includes heart failure with preserved ejection fraction (HFpEF).

What does this new approval mean for the heart failure clinical landscape?

• Until now, there were no approved and clinically effective treatments that address all forms of heart failure, including HFpEF, which has previously been described as the single largest unmet need in cardiovascular medicine. [i],[ii]

• Heart failure is one of the leading causes of avoidable hospitalisations, and readmissions to hospital among people with heart failure leads to poor survival. [iii],[iv],[v]

• Marketing authorisation was granted based on data from the landmark EMPEROR-Preserved Phase III clinical trial, the first of its kind to significantly show a relative reduction in the composite primary endpoint of cardiovascular death or hospitalisation for heart failure with empagliflozin, compared to placebo, on top of standard of care in patients with HFpEF.[vi]

• This marketing authorisation is valid in all EU member states, including the Republic of Ireland.

Neil Johnson, CEO of Croí, Irish patient organisation fighting against heart disease and stroke, and Executive Director of the Global Heart Hub says, “It’s estimated that over 60 million people worldwide are living with heart failure. This complex medical condition very often has a devastating impact on quality of life: physically, emotionally and even financially for those who can no longer work. New treatments for a heretofore underserved population of patients which can improve outcomes and reduce hospital admissions is just great news for patients. The impact of new and emerging treatments on quality of life, from a patient and carer perspective, cannot be overstated because they provide hope and comfort in the knowledge that heart failure can be treated. This in turn has an enormously positive impact on overall mental health and wellbeing by decreasing anxiety, stress and worry.”

The UK authorisation by the Medicines and Healthcare Products Regulatory Agency (MHRA) is anticipated to follow in the coming months. Do let us know if the MHRA announcement will be of interest to cover, as we will have a suite of interview slots available including: people living with heart failure, patient group representatives, healthcare professionals working in the field and a spokesperson from Boehringer Ingelheim.

References on request

NEW – GLUCORX AIDEX - CONTINUOUS GLUCOSE MONITOR

Windzor Pharma are delighted to announce the launch of GlucoRX Aidex to the Irish Market. Aidex is a continuous Glucose Monitor available for all patient types.

The sensors are small and secure and can be used on the arm or the abdomen. Each transmitter has a lifespan of 3 years and each sensor lasts up to 14 days. All data is submitted from the sensor to the GlucoRx Aidex app making it easy to track your glucose levels during the day.

For more information, training or to order please contact orders@windzorpharma.comTransmitters and sensors are available through UDW and Uniphar and PCO. Sensor GMS code 85241