NICE has launched its new medicines advice service to provide “high quality” evidence to the NHS and patients in England on the latest treatments or those with new or updated indications.

The summaries do not constitute formal guidance but aim to support the managed introduction of new drugs for commissioners, budget holders and groups such as prescribing committees.

Professor Mark Baker, Director of the Centre for Clinical Practice at NICE, said the summaries “take the process a step beyond the regulatory requirements” for new treatments to be prescribed.

Summaries are produced by NICE’s Medicines and Prescribing Centre, who expect to publish advice on up to 20 new medicines annually.

Medicines will be considered for summary either at the point of product launch, or up to 12 months in advance of being launched.

Astellas’ Dificlir (fidaxomicin) for the treatment of Clostridium difficile infection (CDI) is the first medication covered as part of the new service. Dificlir is the first in a new class of macrocylic antibiotics recently licensed by the EMA for CDI.

The evidence summary concludes that Dificlir, based on evidence from two randomised controlled trials, is non-inferior to vancomycin in curing patients with mild to severe CDI. Also, its side-effect profile appears similar to that of oral vancomycin and may have advantages in reducing the rate of recurrence.

Astellas’ Dificlir (fidaxomicin), the first new treatment of the hospital super-bug Clostridium difficile infection (CDI) in 50 years, has been launched in the UK.

Dificlir is a first in class antibiotic which Astellas claims halves the rate of recurrence in patients with CDI compared to existing treatment options.

Professor Robert Masterton, Director of the Institute of Healthcare Associated Infection at the University of the West of Scotland, has “high hopes” the treatment will “provide a significant benefit to patients in the UK”.

CDI affects approximately 27,000 people in the UK every year. It costs the NHS an estimated £270m annually to treat the infection.

Recurrence of CDI occurs in up to a quarter of patients within 30 days of initial treatment with existing options.

According to Astellas, clinical trial data showed Dificlir to have a higher clinical cure rate compared to the standard option of care, vancomycin, in patients taking other antibiotics.

The clinical cure rate for patients receiving concomitant antibiotics who received Dificlir was 90.0% compared to 79.4% for patients taking vancomycin.

Also, in those receiving concomitant antibiotics during treatment and/or follow up, treatment with Dificlir compared with vancomycin was associated with 12.3% fewer recurrences.

Graziella Kontkowski, Founder of the C-diff Support patient organisation, said the treatment was a “breakthrough for patients” with CDI but “even more so for those suffering recurrences of the infection.”

Astellas’ oral antibiotic Dificlir offers potential benefits over the standard treatment for C. difficile infection (CDI), according to a new phase III study.

Dificlir (fidaxomicin), which gained EC approval in December 2011, shows a lower rate of recurrence and better sustained response than vancomycin, the current standard of care.

The new treatment has potential to address the growing problem of recurrent and persistent CDI in hospitals and care homes.

Recurrence of CDI occurs in up to 25% of patients within a month of treatment and is the most serious problem in treatment of the disease, according to the European Society of Clinical Microbiology and Infectious Diseases.

In the phase III trial Study OPT-80-004, 5089 adults with CDI in seven European countries and North America received oral Dificlir or oral vancomycin for 10 days.

The results over 30 days showed that Dificlir achieved a lower level of CDI recurrence (12.7% versus 26.9%) and a better level of sustained response or clinical cure without recurrence (76.6% versus 63.4%) than vancomycin.

Professor Oliver Cornely, Medical Director of the Clinical Trial Centre at the University of Cologne, Germany, said: “The high percentage of patients experiencing CDI recurrence remains one of the biggest barriers to improving the management of this severe and sometimes life-threatening condition.

“In this study, Dificlir significantly reduced disease recurrence compared to vancomycin, the current standard of care, showing real promise as an effective treatment alternative for patients with CDI.”

Ken Jones, President and CEO of Astellas Pharma Europe, said: “The results of this study reinforce the strong data we have already seen for Dificlir and support its position as a new and exciting treatment option for CDI.”

Dificlir, first developed by Optimer Pharmaceuticals, is exclusively licensed to Astellas Pharma Europe for development and commercialisation in Europe.

UK-based Astellas Pharma Europe Ltd is a European subsidiary of Tokyo-based company Astellas Pharma Inc.

A new antibiotic to fight the ‘superbug’ Clostridium difficile has received marketing authorisation from the European Commission.

Dificlir (fidaxomicin) from Astellas Pharma, available in tablet form, specifically targets C. difficile bacteria and is more effective in preventing recurrence of the infection than the standard therapy.

The drug, a macrocyclic antibiotic, was developed by US company Optimer Pharmaceuticals and is licensed exclusively to Astellas in Europe.

C. difficile infection (CDI) typically develops in patients where the use of broad-spectrum antibiotics has suppressed the normal intestinal flora. It results in long hospital stays and risk of death.

Despite hygiene measures, C. difficile remains a significant problem in long-term care facilities, with high (25%) rates of recurrence in patients treated with current therapies.

The EC approval of Dificlir followed two phase III clinical studies in Europe and North America, comparing the efficacy and safety of Dificlir with vancomycin (the standard CDI treatment) over 10 days.

While Dificlir achieved the same rate of clinical cure as vancomycin, it was significantly more effective in reducing CDI recurrence and had less negative impact on the normal intestinal flora and on general health.

“The high rate of disease recurrence is the greatest limitation of current treatments for CDI,” said Mark Wilcox, Professor of Medical Microbiology at Leeds Teaching Hospitals. “The significant reduction in disease recurrence by Dificlir compared with vancomycin is a key step to reducing the morbidity associated with CDI, and this new treatment option is a welcome addition that has the potential to improve the patient experience.”

Ken Jones, President and CEO of Astellas Pharma Europe, commented: “Treatment for CDI has changed little in the past 20 years. The EU approval of Dificlir is therefore an important advance.”

The CHMP has recommended Astellas Pharma and Optimer Pharmaceuticals’ Dificlir (fidaxomicin) to treat adults with colon disease.

The drug specifically targets the bacteria causing the infection in the colon whilst avoiding ‘friendly’ bacteria in the gut of patients with the disease, which is also known as Clostridium difficile-associated diarrhoea (CDAD).

Ken Jones, President and CEO of Astellas Pharma Europe, said: “European patients with this potentially fatal disease can take encouragement from the positive CHMP opinion for Dificlir that a new medication for clostridium difficile infection may soon be available.”

Dificlir’s active substance is fidaxomicin, which belongs to the macrocyclic class of antibacterials and inhibits RNA synthesis by bacterial RNA polymerase.

Dr Xavier Luria, Head of Safety and Efficacy at the EMA, said: “This is a promising step forward in the Agency's drive for addressing patients' needs in infectious diseases.”

The positive opinion is based on Phase III clinical research data comparing fidaxomicin with oral vancomycin on patients in the US and Canada. Results of the studies showed that clinical cure was achieved at the end of ten days of treatment with both treatments. Furthermore, fidaxomicin had a significantly lower rate of recurrence of CDI compared to vancomycin.

Dificlir, known as Dificid in the US, was approved by the FDA in May for the treatment of CDAD in adults.

The European Commission will deliver its final decision within three months.

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.

UK-based Astellas Pharma Europe manufactures and distributes pharmaceuticals globally with the intention to improve lives through the introduction of innovative and reliable pharmaceutical products.

Optimer Pharmaceuticals, is a biopharmaceutical company focused on developing and commercialising hospital specialty products to treat serious infections and address unmet medical needs.