HIGH WYCOMBE, England, June 15, 2016 /PRNewswire/ --

Adenuric^® (febuxostat), a treatment for chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis), is now accepted for use in Scotland after a decision by The Scottish Medicines Consortium (SMC).^[1] It is accepted for use in adult patients at intermediate risk of Tumour Lysis Syndrome (TLS) in whom allopurinol is either unsuitable or contraindicated, such as those intolerant to allopurinol (estimated to occur in up to 10% of treated patients)^[2] and those in whom allopurinol is contraindicated, e.g. patients with renal impairment.^[1] The SMC estimates the net budget impact on NHS Scotland will be a saving of £53,000 in year one and a saving of £64,000 in year five, due to the displacement of more expensive treatments.^[1]

TLS is a metabolic syndrome caused by the rapid breakdown of high numbers of tumour cells and is characterised by potentially life-threatening hyperuricaemia, hyperkalaemia, hyperphosphataemia and hypocalcaemia.^[3],[4] Hyperuricaemia results from the build-up of uric acid levels in the blood. The condition can affect patients of all ages, typically in the first few days of chemotherapy and can have severe complications, such as renal failure, cardiac arrhythmias, seizures and, in extreme cases, sudden death.^[3],[4]

Lee Taylor, General Manager, A. Menarini Farmaceutica Internazionale SRL explains: "As the only oral agent approved to prevent cancer-related hyperuricaemia we are delighted that patients in Scotland can potentially benefit from treatment with febuxostat. Febuxostat is already approved for the treatment of hyperuricaemia in patients with gout, and now also represents a cost effective option for those patients in urgent need of TLS treatment. At the Menarini Group we are proud to put patients at the heart of our research and development into innovative new treatments."

Data from the global FLORENCE study, the largest adult trial carried out in TLS prevention, showed febuxostat, an oral selective xanthine-oxidase inhibitor, to be significantly superior to allopurinol, also a xanthine-oxidase inhibitor, at reducing serum uric acid (sUA) levels (514.0 + 225.71 versus 708.0 + 234.42 mg x hour/dl; P <0.0001) in favour of febuxostat, with comparable renal function preservation and safety profiles. Febuxostat was shown to be significantly superior compared with allopurinol in controlling sUA level throughout the whole 8-day treatment period (P<0.0001).^[5] Moreover, the higher efficacy of febuxostat in reducing sUA exposure was confirmed in subgroups of patients with different baseline sUA levels, TLS risk grade, creatinine level, performance status score, and malignant disease.^[5] Febuxostat achieved these results with one fixed daily dose (120mg daily) in comparison to allopurinol that was administered at an adaptable daily dose.^[5]

The SMC's acceptance of febuxostat is based on the pivotal Phase III FLORENCE study of 346 subjects from across 11 European countries and Brazil. The primary objective of the multicenter, randomised, double-blind study, in adults undergoing chemotherapy for haematologic malignancies at intermediate to high risk of TLS, was to determine whether febuxostat fixed dose achieves a better sUA control than allopurinol while preserving renal function in TLS prevention.^[5]

The co-primary end points of the study were, area under the concentration-time curve (AUC) over days 1-8 of sUA and serum creatinine change.^[5] Secondary end points included treatment responder rate, laboratory and clinical TLS incidence and safety.^[5] The most commonly reported adverse events related to the blood and lymphatic system (neutropenia, anaemia, leukopenia, thrombocytopenia, febrile neutropenia), the gastrointestinal system (nausea, diarrhoea, constipation, vomiting), investigations (platelet count decrease), and general disorders and administration site conditions (mucosal inflammation, pyrexia).^[5]

Notes to Editors  

About febuxostat  

Febuxostat is an oral selective xanthine oxidase inhibitor. Febuxostat 120mg is licensed for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of TLS. Febuxostat is also indicated for the treatment of chronic hyperuricaemia in conditions where uric deposition has already occurred including a history, or presence of, tophus and/or gouty arthritis in adults.

About the Menarini Group  

The Menarini Group is the number one Italian pharmaceutical company in the world, 17th in Europe out of 5,389 companies, and 37th company in the world out of 19,992 companies, with a turnover of more than 3,2 billion Euro and 16,457 employees. The Menarini Group has always pursued two strategic objectives: Research and Internationalisation and is present in the most important therapeutic areas including products for cardiology, gastroenterology, pneumology/antibiotics, diabetology, anti-inflammatory agents/analgesics. With 14 production sites and 5 Research and Development centres, the Menarini Group has a strong presence throughout Europe and Asia, Africa, Central and South America. The Menarini group's products are available in more than 100 countries worldwide. For further information please visit http://www.menarini.com

References  

1. SMC website http://www.scottishmedicines.org.uk. SMC number: 1153/16

2. Chohan S. Safety and Efficacy of Febuxostat Treatment in Subjects with Gout and Severe Allopurinol Adverse Reactions. Journal of Rheumatology 2011;38:1957-59

3. Jones GL, et al. Guidelines for the Management of Tumour Lysis Syndrome in Adults and Children with Haematological Malignancies on Behalf of the British Committee for Standards in Haematology. BCSH Guidelines

4. Shields A & Cheesman S. An Evaluation of Febuxostat in the Prevention and Treatment of Tumour Lysis Syndrome. Journal of Formulary & Medicines Management 2015;1(1):12-14

5. Spina M, et al. FLORENCE: A Randomized, Double-Blind, Phase III Pivotal Study of Febuxostat versus Allopurinol for the Prevention of Tumour Lysis Syndrome (TLS) in Patients with Hematologic Malignancies at Intermediate to High TLS Risk. Annal of Oncology 2015;26:2155-61

Date of preparation: June 2016
Job code: PP-AD-UK-0023

SOURCE Menarini Farmaceutica Internazionale SRL