New drug for MS could be approved next month
Hope may be in sight for MS sufferers, thanks to a new drug expected to receive FDA approval in late March 2017. OCREVUS (ocrelizumab), manufactured by Roche Pharmaceuticals, has performed well in clinical trials and has been shown to be especially effective for sufferers of primary progressive MS (PPMS).
Developed by Genentech, part of the Roche Group, OCREVUS was designated a ‘breakthrough therapy’ by the FDA in February 2016, making it the first investigational medicine to receive this designation in respect of MS. Results of a large phase III trial in 2016 indicated that the drug has the potential to significantly slow the progression of physical disability in PPMS sufferers. According to Roche, two major studies have also demonstrated that OCREVUS can be effective in reducing attacks in sufferers of relapsing-remitting MS (RRMS).
Difficult to treat
According to the National MS Society, 2.3 million people worldwide suffer from some form of multiple sclerosis. The disease affects people in different ways, with a wide variety of symptoms and possible prognoses, so it is notoriously difficult to treat. While several drugs are claimed to be effective for RRMS, none are currently available which are designed specifically to treat PPMS.
Injectable disease-modifying drugs (DMD) provide relief for some sufferers, while others respond better to oral medication. However, some sufferers have not found any FDA-approved drug helpful in easing symptoms, lessening the frequency of flare-ups or slowing down the progression of their MS.
CD20-positive B cells are believed to be a primary cause of damage to myelin (which provides insulation and support to nerve cells) and axonal (nerve cell), and this can cause disability in MS sufferers. OCREVUS has been formulated specifically to target the B cells which are thought to be responsible for myelin sheath damage and repair.
Relief in sight?
An FDA 510k clearance submission must be submitted by the manufacturer of any new medication, in order for it to be approved. Such submissions are often fast-tracked by third-party review organisations, such as http://www.fdathirdpartyreview.com/ to speed the process along. FDA approval of OCREVUS was delayed in December 2016, due to manufacturing issues.
If approved, the drug will be welcomed by sufferers of PPMS in particular, as there are currently no medications available which are specifically formulated to slow the disease’s progression and improve symptoms.