The Therapeutic Goods Administration (TGA) has approved TECFIDERA™ (dimethyl fumarate) as a new oral treatment for Australian patients with relapsing multiple sclerosis (MS) to reduce the frequency of relapses and to delay the progression of disability.
Tecfidera (also known previously as BG-12) is a drug which has both anti-inflammatory and neuroprotective properties. The compound dimethyl fumarate has been used for many years as a treatment for psoriasis in Europe.
Clinical trials have shown that Tecfidera can reduce relapse rates in comparison with placebo and also reduced disability progression in people with relapsing remitting MS.
The most common side effects of Tecfidera include flushing, skin reactions, nausea, vomiting, diarrhoea and abdominal pain. Less common but more serious side effects of Tecfidera include effects on the kidneys, reduction in lymphocytes (white blood cells) and increased risk of infections.
The Therapeutic Goods Administration (TGA) is responsible for evaluating the efficacy and safety of new medications. TGA approval and registration on the Australian Register of Therapeutic Goods is required before medications can be prescribed.
The makers of Tecfidera, Biogen Idec Australia, have advised that they will be reviewing the official notification from the TGA and will then make arrangements to make Tecfidera available to Australians with MS. This may initially include a patient familiarisation program which would be available to suitable patients via specific medical specialists.
Broader availability of Tecfidera awaits the current review by the Pharmaceutical Benefits Advisory Committee (PBAC). Their recommendations are expected later in August.
The PBAC is required to consider a number of factors when making recommendations, including the clinical efficacy and cost-effectiveness of a treatment relative to other medicines and the cost to the government of a new listing. The PBAC recommendations must then receive final approval by the Federal Government before listing on the Pharmaceutical Benefits Scheme (PBS).
If approved for listing on the PBS, this treatment would provide another affordable treatment option for Australians with MS. As people with MS respond differently to treatments and side-effect profiles differ, a wider range of treatment choices is a welcome development.
For further details please see the Consumer Medicine Information sheet for Tecfidera, which can be found on the TGA website here.