A new first-in-class antibiotic has been recommended in the UK for treatment of severe Clostridium difficile infection (CDI).

New guidance from Public Health England recommends Dificlir (fidoxamicin) from Astellas for adults with severe CDI and high risk of recurrence, or for recurrent CDI.

This makes the drug available for those CDI patients who are at highest risk, including those with multiple conditions.

CDI, a bacterial infection, is predominantly hospital-acquired and is potentially fatal, with 27,000 cases in the UK each year leading to 3,000 deaths.

In clinical trials, Dificlir showed similar efficacy and safety to the current standard treatment, vancomycin, but more than halved the rate of recurrence.

Recurrence of CDI is the greatest problem encountered in treatment of the infection, occurring in up to 25% of patients within 30 days of treatment.

The NHS has identified CDI control as a key aspect of patient safety, with targets for reduction in cases that may be enforced by financial penalties.

The targets demand a reduction in CDI infections over 2013/2014 of 30% (on average) for acute trusts and 21% (on average) for CCGs.

Dr Simon Goldenberg, consultant microbiologist, said the new guidance was “a huge step forward in being able to improve the overall management of CDI,” offering a “very welcome” opportunity to “bring down rates of infection”.

Graziella Kontkowski, founder of the patient group C-diff Support, noted that while CDI rates have fallen in hospitals they have risen in the community. She described the new guidance as “good news for patients” that “will encourage a more rigorous approach to reducing both new and recurrent cases of the infection.”

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.

A new antibiotic to treat C. difficile infection (CDI) has been approved for restricted use by the Scottish Medicines Consortium (SMC).

Dificlir (fidoxamicin) from Astellas Pharma is accepted within NHS Scotland for treatment of adults with a first CDI recurrence on the advice of a specialist.

SMC declined to approve the drug for first-line use in adults with severe CDI.

The decision was based on clinical trial data showing Dificlir to be similar in efficacy to vancomycin (the standard treatment) as a first-line therapy for CDI, but twice as effective in treating recurrent CDI.

CDI is a serious healthcare-acquired infection often linked to use of broad-spectrum antibiotics. It increases hospital stays by three days and treatment costs by 50% on average, with complications including bowel surgery.

In Scotland, which has suffered a number of CDI outbreaks, the disease affects over 2,000 people each year, costing over £2m and causing death in 10% of cases.

Dificlir is an oral medication that acts locally on C. difficile bacteria in the gut, blocking their metabolism and reducing the growth of the infection.

Professor Robert Masterton, Director of the Institute of Healthcare Associated Infection at the University of the West of Scotland, said: “With the increasing elderly population the threat of further CDI outbreaks cannot be ignored. 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.”

An Astellas spokesperson said the company would continue to gather data to support the use of Dificlir as a first-line CDI therapy.

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 may help to treat C. difficile infections (CDI) in cancer patients receiving chemotherapy, according to new studies.

Dificlir (fidaxomycin) may offer this patient group better prospects of clinical cure and sustained clinical cure with less risk of recurrence than vancomycin, the current standard treatment for CDI.

Cancer patients are particularly at risk of CDI due to their long hospital stays and the negative impact of chemotherapy on immunity.

A recent phase III trial showed Dificlir to be more effective than vancomycin in preventing recurrence of CDI, a major issue in treatment of the dangerous ‘superbug’.

Post-hoc analysis of data from that and another trial focused on 183 patients with CDI who had a current diagnosis of cancer. This sub-group showed higher rates of clinical cure (97.3% versus 87.5%) and sustained clinical cure (83.6% versus 61.3%) as well as reduced rates of recurrence (14.1% versus 30.0%) when treated with Dificlir rather than vancomycin.

Professor Oliver Cornely, Medical Director of the Clinical Trial Center of The University of Cologne, Germany, commented: “Patients with cancer represent a vulnerable population who are at high risk of CDI, often resulting from their compromised immune system. CDI can be a devastating addition for patients who are already battling pre-existing conditions. Treatment options that reduce the burden of CDI, and in particular recurrence, will allow clinicians to focus their efforts on treating the cancer.”

“Results from key Phase III trials and the post-hoc analysis demonstrate the effectiveness of Dificlir as a novel and effective treatment in patients with CDI, but also in high-risk populations, such as patients with cancer,” said Ken Jones, CEO of Astellas Pharma Europe.

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

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

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.