WCN 2019 Discussions Point to Failures of Regulators to Make MS Therapies Available

There is a sizable gap between advancements in treatment for multiple sclerosis (MS) and their regulatory approval, which is a circumstance that necessitates increased  advocacy on a global scale.

This concern was a major topic of conversation recently at the XXIV World Congress of Neurology (WCN 2019) in Dubai, United Arab Emirates.

In recent years, especially in the past decade, there has been a surge in MS therapies that have undergone development, entered clinical trials, and  obtained regulatory approval.

“Few neurological conditions have seen advancements like that in the study of MS,” Alan Thompson, MD, said in a press release from the World Federation of Neurology (WFN), the organization that hosted WCN 2019. Thompson is chair of the Scientific Steering Committee of the International Progressive MS Alliance.

“MS has gone from being an untreatable condition to being a manageable disease which is an extraordinary story of achievement, but there is still a long way to go,” Thompson said. 

Despite recent progress, there often remains a disconnect between successful treatments in clinical trials, and those same treatments being approved by regulatory agencies. This is a concern on a global level because it invariably means that some people with MS won’t be able to access therapies that could be beneficial for them.

Indeed, there are regions where regulatory restrictions and/or delays prevent doctors from prescribing certain medications, which, according to the WFN, means that MS patients in these regions are more likely to experience disease progression or exacerbated disability.

“We have found that drugs do modify the disease,” said Bill Carroll, MD, president of the WFN and a neurologist at Sir Charles Gairdner Hospital in Perth, Western Australia.

But, Carroll noted, implementing these in practice often is hampered by “outdated clinical phenotypes” that are being found to poorly represent what actually happens in MS — although they are still being employed at the regulatory level.

According to Thompson, moving past these hurdles will require global initiatives to raise awareness and expand access to care. “International initiatives and awareness will help unlock greater funding for MS research and lead to more effective treatments,” he said.

“Our patients should be the number one priority,” Carroll said. “And it’s time for neurologists and MS physicians to adopt the approach that they should consider prescribing what is most appropriate for their patients today, despite what restrictions may have [been] put in place yesterday by regulators.”