Drug may help slow the advance of progressive MS for first time

The development has been welcomed by MS Society Scotland which said: "It's really significant as it’s the first time phase three clinical trials have shown a positive result in primary progressive MS - so it’ll offer a lot of hope to people."

Scotland has one of the highest incidences of MS in the world with some experts linking it to the lack of naturally occurring vitamin D because of a lack of sunlight.

The disease is thought to be caused by the immune system attacking the central nervous system, causing problems with balance, vision, speech and tremors.

About 85 percent of patients have a form called relapsing-remitting MS, characterised by sporadic neurologic attacks followed by periods of remission. Primary progressive MS affects about 10 to 15 per cent of people diagnosed and is so called because symptoms get gradually worse over time.

Roche have said they aiming to apply for an EU license for ocrelizumab next year. That means if licensing is successful, it could potentially become available in 2017.

The drug cut clinical disability by nearly a quarter in a separate study of patients with primary progressive multiple sclerosis (PPMS), and for which there is currently no approved treatment.

It also cut multiple sclerosis relapses by nearly 50 percent compared with the older product Rebif in two large clinical trials, underscoring its potential in the main relapsing form of the disease.

The Swiss company had previously said its new drug worked in both settings but the scale of effect was only being disclosed this week at the European Committee for Treatment and Research in Multiple Sclerosis congress in Barcelona.

Nick Rijke,  executive director for policy and research at the MS Society Scotland said: “These phase 3 trial results will provide a great deal of hope for people with primary progressive MS, who currently don’t have any treatments available that can slow down the worsening of their condition.

"Finding effective treatments for multiple sclerosis is our number one priority at the MS Society and this is a big moment.

“So far only the top line results from this trial have been announced, so we look forward to seeing the full details with great anticipation. We hope such an encouraging outcome will stimulate further progress in beating this disease.”

Professor Gavin Giovannoni, of Barts and The London School of Medicine, said: "The results are a game changer for the clinical community.

"The important next step is for regulators to enable...treatment to be provided as soon after diagnosis as possible to provide optimal outcomes, with the potential to improve patients' quality of life in the long-term."

"For decades, we've tried different medicines to treat this primary progressive forms of the disease and nothing has worked," said Dan O'Day, Roche chief operating officer of Pharmaceuticals. "Ocrelizumab is the first medicine to show an effect in significantly reducing the progression for patients with progressing multiple sclerosis. We're very excited about the benefit that could bring to patients."

In the two relapsing MS trials, the new drug reduced the annual relapse rate by 46 and 47 percent compared to Merck KGaA's Rebif, while the rate of confirmed disability progression (CDP) was 37 and 43 percent lower.

Rebif, an interferon drug, already reduces the number of relapses by around a third.

Roche's head of neuroscience clinical development Paulo Fontoura said: "The Phase III results are a significant first in MS therapy.

"Over a two year period we have demonstrated that ocrelizumab is superior to Rebif, which is a standard of care medicine in significantly reducing all three main markers of the disease activity while keeping a similar safety profile."

Drug safety is critical in MS, since the disease is caused by abnormal immune system attacks on the protective sheath surrounding nerve cells and treatments need to adjust the body's response, which can lead to problems such as infections.

Ocrelizumab is given by infusion once every six months, significantly less frequently than most other MS medicines.

In 2013, an 'Atlas of MS' - produced by the Multiple Sclerosis International Federation - showed that the prevalence of the disease in Scotland was 188 cases per 100,000 people in the population, slightly behind Northern Ireland at 190 but higher than the 138 cases in Wales and 162 in England.

This revealed that, at that time, around 10,000 people were living with the condition in Scotland.