Astellas' Dificlir is now routinely available for National Health Service patients in Wales after advisors recommended the drug's use for treating the hospital superbug C. difficile.
The All Wales Medicines Strategy Group (AWMSG), which advises on prescribing new treatments in Wales, has accepted Dificlir (daxomicin) for restricted use within NHS Wales for the treatment of CDI, specifically in adults with severe or recurring cases.
Approved in Europe in December last year, Dificlir is a first-in-class macrocyclic antibiotic indicated for the treatment of the hospital superbug C. difficile, which can cause severe diarrhoea and even death.
In July this year, an evidence summary published by NICE concluded that clinical trials of Dificlir, the first new weapon against the superbug in 50 years, have shown that it has a similar efficacy and safety profile to that of the current gold standard of treatment, vancomycin.
However, crucially, it also significantly cut the rate of disease recurrence, which occurs in up to 25% of patients within 30 days of initial treatment, and is therefore a crucial factor in treatment outcomes for patients.
The cost to the NHS of treating CDI in Wales is estimated to be in excess of £20 million a year, and Graziella Kontkowski, founder of C-diff Support, has welcomed the AWMSG's decision to accept Dificlir's use in the country.
"The availability of a new medicine for Welsh patients will be hugely beneficial, hopefully limiting the likelihood of recurrent infection, reducing the burden on patients as well as NHS budgets," she said.