Accessibility Statement Skip Navigation
  • Resources
  • Blog
  • Journalists
  • +44 (0)20 7454 5110
  • Client Login
  • Send a Release
Return to PR Newswire homepage
  • News
  • Products
  • Contact
When typing in this field, a list of search results will appear and be automatically updated as you type.

Searching for your content...

No results found. Please change your search terms and try again.
  • News in Focus
      • Browse News Releases

      • All Public Company News
      • All Multimedia News
      • View All News Releases

      • Regulatory News

      • D/A/CH Regulatory News
      • UK Regulatory News
      • View All Regulatory News

  • Business & Money
      • Auto & Transportation

      • Aerospace & Defense
      • Air Freight
      • Airlines & Aviation
      • Automotive
      • Maritime & Shipbuilding
      • Railroads & Intermodal Transportation
      • Supply Chain/Logistics
      • Transportation, Trucking & Railroad
      • Travel
      • Trucking & Road Transportation
      • View All Auto & Transportation

      • Business Technology

      • Blockchain
      • Broadcast Tech
      • Computer & Electronics
      • Computer Hardware
      • Computer Software
      • Data Analytics
      • Electronic Commerce
      • Electronic Components
      • Electronic Design Automation
      • Financial Technology
      • High Tech Security
      • Internet Technology
      • Nanotechnology
      • Networks
      • Peripherals
      • Semiconductors
      • View All Business Technology

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Financial Services & Investing

      • Accounting News & Issues
      • Acquisitions, Mergers & Takeovers
      • Banking & Financial Services
      • Bankruptcy
      • Bond & Stock Ratings
      • Conference Call Announcements
      • Contracts
      • Cryptocurrency
      • Dividends
      • Earnings
      • Earnings Forecasts & Projections
      • Financing Agreements
      • Insurance
      • Investments Opinions
      • Joint Ventures
      • Mutual Funds
      • Private Placement
      • Real Estate
      • Restructuring & Recapitalisation
      • Sales Reports
      • Shareholder Activism
      • Shareholder Meetings
      • Stock Offering
      • Stock Split
      • Venture Capital
      • View All Financial Services & Investing

      • General Business

      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • Environmental, Social and Governance (ESG)
      • Human Resource & Workforce Management
      • Licensing
      • New Products & Services
      • Obituaries
      • Outsourcing Businesses
      • Overseas Real Estate (non-US)
      • Personnel Announcements
      • Real Estate Transactions
      • Residential Real Estate
      • Small Business Services
      • Socially Responsible Investing
      • Surveys, Polls & Research
      • Trade Show News
      • View All General Business

  • Science & Tech
      • Consumer Technology

      • Artificial Intelligence
      • Blockchain
      • Cloud Computing/Internet of Things
      • Computer Electronics
      • Computer Hardware
      • Computer Software
      • Consumer Electronics
      • Cryptocurrency
      • Data Analytics
      • Electronic Commerce
      • Electronic Gaming
      • Financial Technology
      • Mobile Entertainment
      • Multimedia & Internet
      • Peripherals
      • Social Media
      • STEM (Science, Tech, Engineering, Math)
      • Supply Chain/Logistics
      • Wireless Communications
      • View All Consumer Technology

      • Energy & Natural Resources

      • Alternative Energies
      • Chemical
      • Electrical Utilities
      • Gas
      • General Manufacturing
      • Mining
      • Mining & Metals
      • Oil & Energy
      • Oil & Gas Discoveries
      • Utilities
      • Water Utilities
      • View All Energy & Natural Resources

      • Environ­ment

      • Conservation & Recycling
      • Environmental Issues
      • Environmental Policy
      • Environmental Products & Services
      • Green Technology
      • Natural Disasters
      • View All Environ­ment

      • Heavy Industry & Manufacturing

      • Aerospace & Defence
      • Agriculture
      • Chemical
      • Construction & Building
      • General Manufacturing
      • HVAC (Heating, Ventilation & Air-Conditioning)
      • Machinery
      • Machine Tools, Metalworking & Metallurgy
      • Mining
      • Mining & Metals
      • Paper, Forest Products & Containers
      • Precious Metals
      • Textiles
      • Tobacco
      • View All Heavy Industry & Manufacturing

      • Telecomm­unications

      • Carriers & Services
      • Mobile Entertainment
      • Networks
      • Peripherals
      • Telecommunications Equipment
      • Telecommunications Industry
      • VoIP (Voice over Internet Protocol)
      • Wireless Communications
      • View All Telecomm­unications

  • Lifestyle & Health
      • Consumer Products & Retail

      • Animals & Pets
      • Beers, Wines & Spirits
      • Beverages
      • Bridal Services
      • Cannabis
      • Cosmetics & Personal Care
      • Fashion
      • Food & Beverages
      • Furniture & Furnishings
      • Home Improvement
      • Household, Consumer & Cosmetics
      • Household Products
      • Jewellery
      • Non-Alcoholic Beverages
      • Office Products
      • Organic Food
      • Product Recalls
      • Restaurants
      • Retail
      • Supermarkets
      • Toys
      • View All Consumer Products & Retail

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Health

      • Biometrics
      • Biotechnology
      • Clinical Trials & Medical Discoveries
      • Dentistry
      • FDA Approval
      • Fitness/Wellness
      • Health Care & Hospitals
      • Health Insurance
      • Infection Control
      • International Medical Approval
      • Medical Equipment
      • Medical Pharmaceuticals
      • Mental Health
      • Pharmaceuticals
      • Supplementary Medicine
      • View All Health

      • Sports

      • General Sports
      • Outdoors, Camping & Hiking
      • Sporting Events
      • Sports Equipment & Accessories
      • View All Sports

      • Travel

      • Amusement Parks & Tourist Attractions
      • Gambling & Casinos
      • Hotels & Resorts
      • Leisure & Tourism
      • Outdoors, Camping & Hiking
      • Passenger Aviation
      • Travel Industry
      • View All Travel

  • Policy & Public Interest
      • Policy & Public Interest

      • Animal Welfare
      • Corporate Social Responsibility
      • Economic News, Trends & Analysis
      • Education
      • Environmental
      • European Government
      • Labour & Union
      • Natural Disasters
      • Not For Profit
      • Public Safety
      • View All Policy & Public Interest

  • People & Culture
      • People & Culture

      • Aboriginal, First Nations & Native American
      • African American
      • Asian American
      • Children
      • Diversity, Equity & Inclusion
      • Hispanic
      • Lesbian, Gay & Bisexual
      • Men's Interest
      • People with Disabilities
      • Religion
      • Senior Citizens
      • Veterans
      • Women
      • View All People & Culture

  • Overview
  • Distribution
  • Paid Placement
  • Multichannel Amplification
  • Disclosure Services
  • SocialBoost
  • Rooms
    • MediaRoom
    • ESG Rooms
  • AI Tools
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Hamburger menu
  • Cision PR Newswire UK provides press release distribution, targeting, monitoring, and marketing services
  • Send a Release
    • Phone

    • +44 (0)20 7454 5110 from 8 AM - 5:30 PM GMT

    • ALL CONTACT INFO
    • Contact Us

      +44 (0)20 7454 5110
      from 8 AM - 5:30 PM GMT

  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • News in Focus
    • Browse News Releases
    • Regulatory News
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
  • Policy & Public Interest
    • Policy & Public Interest
  • People & Culture
    • People & Culture
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • Overview
  • Distribution
  • Paid Placement
  • Multichannel Amplification
  • Disclosure Services
  • Cision Communications Cloud®
  • AI Tools
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists

Scottish Medicines Consortium Accepts Adenuric® (Febuxostat) for the Prevention and Treatment of Hyperuricaemia and Predicts Savings for NHS Scotland


News provided by

Menarini Farmaceutica Internazionale SRL

15 Jun, 2016, 08:00 GMT

Share this article

Share toX

Share this article

Share toX

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

Modal title

Contact PR Newswire

  • +44 (0)20 7454 5110
    from 8 AM - 5:30 PM GMT
  • General Enquiries
  • Media Enquiries
  • Partnerships

Products

  • Content Distribution
  • Multimedia Services
  • Disclosure Services
  • Cision Communications Cloud®

About

  • About PR Newswire
  • About Cision
  • Partnering Opportunities
  • Careers
  • Accessibility Statement
  • APAC
  • APAC - Simplified Chinese
  • APAC - Traditional Chinese
  • Brazil
  • Canada
  • Czech
  • Denmark
  • Finland
  • France
  • Germany
  • India
  • Indonesia
  • Israel
  • Japan
  • Korea
  • Mexico
  • Middle East
  • Middle East - Arabic
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • United States
  • Vietnam

My Services

  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
  • Data Privacy

Do not sell or share my personal information:

  • Submit via Privacy@cision.com 
  • Call Privacy toll-free: 877-297-8921

Contact PR Newswire

Products

About

My Services
  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
+44 (0)20 7454 5110
from 8 AM - 5:30 PM GMT
  • Terms of Use
  • Privacy Policy
  • Information Security Policy
  • Site Map
  • RSS
  • Cookie Settings
Copyright © 2025 PR Newswire Europe Limited. All Rights Reserved. A Cision company.