Breakthrough treatment now available in Scotland for potentially fatal hospital-acquired infection
Egham, UK, 9th July 2012 – The Scottish Medicines Consortium (SMC), which advises NHS Scotland on prescribing new treatments, announced today that DIFICLIR (fidaxomicin), a first in class antibiotic for Clostridium difficile infection (CDI), is accepted for restricted use within NHS Scotland for the treatment of adults with a first CDI recurrence on the advice of local microbiologists or specialists in infectious diseases.1 CDI is a potentially fatal, hospital-acquired infection that affects over 2,000 people in Scotland per year2 and in 2010, contributed to 270 deaths.3
Professor Robert Masterton, Director of the Institute of Healthcare Associated Infection at the University of the West of Scotland, commented, “This is excellent news for patients in Scotland. Although there has been much improvement in the management of CDI in Scotland in recent years, it is still a major cause of hospital-acquired infection. The approval of fidaxomicin represents a notable milestone in combating the still significant impact and spread of this disease.”
An Astellas Pharma Ltd. spokesperson quoted, “We are pleased that patients in Scotland will now be able to access fidaxomicin. Fidaxomicin reduces recurrence by almost a half compared to the current gold standard and we believe that when used earlier on, it has the potential to significantly reduce burden to patients and also reduce the financial burden to the NHS of additional bed days. As such, Astellas believe that most benefit can be gained when fidaxomicin is used as a first line treatment for CDI. Astellas is committed to patients with CDI and will continue to gather additional data to further support this position. Astellas will also continue to work in partnership with the SMC.”
In clinical trials, fidaxomicin demonstrated a similar efficacy and tolerability profile to the current “gold standard” vancomycin (primary endpoint), but more than halved the rate of recurrence in patients with CDI compared to vancomycin (planned secondary endpoint, 12.7% versus 26.9%, p=0.0002).4 Recurrence of CDI occurs in up to 25% of patients
within 30 days of initial treatment with current therapies4,5 and has been identified as the most important problem in the treatment of CDI.6
In recent years Scotland has seen a number of high profile CDI outbreaks including Scotland’s worst outbreak at the Vale of Leven Hospital, which triggered the Vale of Leven Hospital Inquiry to investigate the occurrence of CDI and deaths caused by it. Although the introduction of a mandatory CDI surveillance programme in 2006 has contributed to a drop in cases across all age groups, CDI continues to be recognised as one of the most important healthcare associated infections.7
Professor Masterton continued, “Although CDI can affect anyone at any age, it is the over-65s who are most vulnerable to infection. With the increasing elderly population the threat of further CDI outbreaks cannot be ignored. It poses a risk not only in hospitals, but in nursing homes and other long-term care facilities. It is important that we employ all possible measures to contain this disease. Widespread and early access to the new antibiotic fidaxomicin will, I believe, make a real difference.”
CDI results from infection of the internal lining of the colon by C. difficile bacteria. Severe cases can require bowel surgery and even lead to death. The cost to the NHS of treating CDI in Scotland is estimated to be in excess of £2 million a year.2,8
In February 2011, Astellas Pharma Europe Ltd., the European Headquarters of Astellas Pharma Inc., was granted exclusive rights to develop and commercialise fidaxomicin in Europe and certain other countries in the Middle East, Africa and the Commonwealth of Independent States (CIS) by Optimer Pharmaceuticals, Inc .The European Commission granted Marketing Authorisation for fidaxomicin tablets for the treatment of adults with Clostridium difficile infections (CDI), also known as Clostridium difficile – associated diarrhoea (CDAD), in December 2011.
About the SMC guidance
fidaxomicin (Dificlir®) is accepted for restricted use within NHS Scotland.
Indication: treatment of adults with Clostridium difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD).
SMC restriction: Treatment of adults with a first CDI recurrence only on the advice of local microbiologists or specialists in infectious diseases.
Fidaxomicin demonstrated non-inferiority to another antibiotic in the clinical cure* of Clostridium difficile infection and superiority in reducing recurrence.
The submitting company did not present a sufficiently robust economic analysis to gain acceptance by SMC for first-line use in adults with severe CDI.
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NOTES TO EDITORS:
About Clostridium Difficile Infection (CDI)
CDI is a serious illness resulting from infection of the internal lining of the colon by C. difficile bacteria. The bacteria produce toxins that cause inflammation of the colon, diarrhoea and, in some cases, death. Patients typically develop CDI after the use of broad-spectrum antibiotics that disrupt normal bowel flora, allowing C. difficile bacteria to flourish. The risk of CDI and disease recurrence is particularly high in patients aged 65 years and older9 but also affects younger patients. CDI results in substantial costs to healthcare systems, in particular because of extended hospitalisation.10 Hospitalised patients with CDI have a longer hospital stay of 3.6 days and 54% higher adjusted hospital costs compared with those without CDI.11
About the clinical trials
Lancet Infectious Diseases
In the multi-centre, double-blind, randomised, non-inferiority Phase III trial (known as Study OPT-80-004), 509 adults with CDI in seven European countries, including the UK, and North America received 400mg/day oral fidaxomicin or 500mg/day oral vancomycin for 10 days. The proportion of subjects in whom clinical cure* was achieved were similar for the two treatments (87.7% vs. 86.8% respectively) meaning that fidaxomicin met the primary endpoint of non-inferiority to vancomycin. Also, fidaxomicin recipients were more likely than those treated with vancomycin to experience a sustained antibiotic response (clinical cure without recurrence) within 30 days of completing treatment (76.6% vs. 63.4% respectively, p=0.001).4
New England Journal of Medicine
In the prospective, multicentre, double-blind, randomised, parallel-group Phase III trial (known as OPT-80-003), 629 patients aged 16 years or older were randomised to treatment with 400mg/day oral fidaxomicin or 500mg/day oral vancomycin for 10 days, of whom 596 (287 with fidaxomicin; 309 with vancomycin) could be evaluated for the modified intention-to-treat analysis. Results showed that significantly fewer patients in the fidaxomicin group than in the vancomycin group had a recurrence (15.4% vs. 25.3%, p=0.005).12
Clinical Infectious Diseases
Data from two Phase III clinical trials were pooled and analysed to study the effect of concomitant antibiotics on the response to fidaxomicin or vancomycin. The results demonstrated that the clinical cure* rate for patients who received fidaxomicin was 90.0% versus 79.4% for vancomycin (P=0.04). In patients receiving concomitant antibiotics during treatment and/or follow up, treatment with fidaxomicin compared with vancomycin was associated with 12.3% fewer recurrences (16.9% vs 29.2%; p=0.048).13
*Please note: clinical cure was defined as the resolution of diarrhoea for the duration of treatment and no need for further CDI therapy two days after completion of study medication, as determined by the investigator.
About the SMC
The remit of the Scottish Medicines Consortium (SMC) is to provide advice to NHS Boards and their Area Drug and Therapeutics Committees (ADTCs) across Scotland about the status of all newly licensed medicines, all new formulations of existing medicines and new indications for established products (licensed from January 2002). For more information, visit http://www.scottishmedicines.org.uk/home
About Astellas Pharma Ltd.
Astellas is one of the leading pharmaceutical companies in the world. As a young, forward thinking company with a rich heritage, Astellas is dedicated to improving peoples’ lives through the introduction of innovative and reliable pharmaceutical products. In everything we do we are guided by our ethos of CHANGING TOMORROW to create a brighter future for all our stakeholders – above all for patients.
Astellas’ key strengths lie in the therapy areas of Transplantation, Urology, Dermatology, Anti-Infectives and Pain Management. In addition, Astellas is committed to growing a strong presence in the field of Oncology.
Last updated on: 10/07/2012