The Australian Therapeutic Goods Administration (TGA) has approved Ocrevus (ocrelizumab) for the treatment of multiple sclerosis in Australia.
Ocrevus’s TGA approval has been highly anticipated, not only because it is potentially another effective medication for relapsing remitting MS but because it is also the first ever medication approved for the treatment of primary progressive MS.
Being listed as a treatment for primary progressive MS is a huge step forward. Ocrevus showed a modest slowing of progression in clinical trials, but it is exciting as it is the first time a treatment has shown efficacy for PPMS. It opens up this field of research by showing it is possible to develop treatments for this previously refractory disease.
The dire lack of treatment options for progressive MS has spurred MS Research Australia to take a leading role in the International Progressive MS Alliance which has the mission to accelerate the development of progressive MS treatments.
Now that Ocrevus is approved for use, we are hoping that it will be also be included on the Pharmaceutical Benefits Scheme (PBS), which will make the drug more affordable for all Australians who need it. Currently, the Pharmaceutical Benefits Advisory Committee (PBAC) who advises the government on which medications should be made available on the PBS are considering Ocrevus. They are expected to make their decision for relapsing MS at its meeting in July 2017, and for primary progressive MS at its meeting in November 2017.
The PBAC takes into consideration the thoughts and opinions of members of the public, health professionals and organisations when assessing new medications. As we do for all new, proven medications for MS, MS Research Australia has been advocating for the inclusion of Ocrevus on the PBS. We believe that everyone with MS should be able to affordably access all treatment options which could be of benefit.
Ocrevus was also recently approved for use by the US Food and Drug Administration for relapsing and primary progressive MS and is also under consideration by the European Medicines Agency.
The assessment by the TGA was based primarily on the results of two phase III clinical trials in relapsing MS, known as OPERA I and OPERA II, and one phase III trial in PPMS, known as Oratorio. In these studies, it was found that Ocrevus reduced the relapse rates, slowed the progression of disability, reduced the number of new lesions, slowed the expansion of current lesions, and reduced overall brain volume loss. You can view our earlier detailed article on the clinical trials results here.
Ocrevus is given as two intravenous infusions once every six months. It is a monoclonal antibody (a type of antibody that recognises a single specific target) that blocks the activity of specific immune cells. These immune cells are called B cells and the antibody targets a molecule called CD20 which is found on the surface of these cells.
MS Research Australia looks forward to the PBAC recommendations regarding this new MS medication. The addition of a further affordable treatment option for relapsing MS will be a welcome development that will enable people with MS and their doctors to find effective therapies suited to their individual circumstances.
Individuals with MS should discuss treatment options with their neurologist.