This week, BrainStorm Cell Therapeutics issued a news release announcing its intent to seek early regulatory approval to distribute its Amyotrophic Lateral Sclerosis (ALS) product to patients in Canada. This news was eagerly received by patient groups in Canada and internationally.
ALS, also known as Lou Gehrig’s Disease, is a progressive neuromuscular disease in which nerve cells die and muscles are paralyzed. It is fatal and current treatments are inadequate. Thanks to the #icebucketchallenge social media sensation, there is growing awareness of ALS, and the American A.L.S. Association has raised over $115 million for research – leading to the discovery of a new gene, NEK1, tied to ALS. (To learn more about ALS and to seek support, visit ALS Canada and its international counterparts.)
The fact that BrainStorm is interested in trying to get its product NurOwn® approved for distribution in Canada is exciting for patients, but this will take some time. CCRM is providing regulatory consulting to help BrainStorm navigate a special regulatory pathway for approval with Health Canada. Contrary to the optimistic interview that aired on CTV Your Morning (see below), BrainStorm is not bringing an ALS clinical trial to Canada. However, if BrainStorm qualifies for this pathway and its market authorization request is successful, it is possible that NurOwn could be available for patients in Canada by early 2018 (i.e. if there are no delays, all the criteria are met, and there is sufficient supportive evidence).
Regulatory authorization is an important step towards access. There are other steps necessary before emerging and novel products will be available to Canadians. In particular, the Canadian clinical community must be prepared to administer the products, and public or private payers must be willing to pay for them. True access to improved treatments for Canadian ALS patients would be a great outcome and something we are all hoping for.
So, if you read the news release and watched the CTV piece and you were left feeling confused by the different messages, I hope everything is clear now. By the way, CTV has changed the headline of its video and added a short factual article that should also help clear up the confusion. Here it is if you missed it.
Our regular feature, Right Turn, appears every Friday and we invite you to submit your own blog to info(at)ccrm.ca. We encourage you to be creative and use the right (!) side of your brain. We dare you to make us laugh! Right Turn features cartoons, photos, videos and other content to amuse, educate and encourage discussion.
As always, we welcome your feedback in the comment section.
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