American patient groups and neurologists have clearly been giving Ocrevus (ocrelizumab) plenty of attention since news of its approval landed, as a sweep of U.S. reaction to the FDA’s decision showed. But what is happening elsewhere in regard to this first treatment for both primary progressive and relapsing multiple sclerosis (MS)?
Genentech submitted approval applications last year to health authorities in Canada, the European Union (EU), Australia, and Switzerland. But a look at the media activity in these regions makes it clear that — outside the U.S. — patient representatives are not celebrating just yet.
The EU, along with the other countries, have independent regulatory authorities that make decisions based on their own review of the clinical trials data. Their respective appraisals are processes not linked to the U.S. Food and Drug Administration decision.
Approvals of a drug by various health authorities often lead to identical, or very similar, prescription labels. But such approvals can differ. And, in rare cases, a drug can be approved in the U.S. but be rejected elsewhere.
The European Medicines Agency (EMA), or other health authorities, for instance, could approve Ocrevus for primary progressive, but not relapsing MS.
The MS Society of Canada informed its members of Ocrevus’ approval by the FDA with a short announcement, noting the drug is currently under review by Health Canada. It plans to provide more updates as information becomes available.
But the Canadian Society also underscored that Ocrevus has the potential to advance MS treatment in ways beyond itself.
“While ocrelizumab represents an important milestone in MS treatment, the MS research community is focused on gaining a deeper understanding of the biological mechanisms underlying progressive MS, and this treatment sheds light on this mechanism,” the society wrote.
Only if given a positive reception as to its costs and benefits will Ocrevus become available through the U.K. National Health Service (NHS). This extra step makes for additional waiting for U.K. patients. But the U.K. MS Society assures patients that it will be feeding into the reviews.
Although the FDA approval does not impact the European assessment, Pam Macfarlane, chief executive of the MS Trust, is hopeful.
“This is an encouraging step forward for people with PPMS [primary progressive MS] in the USA,” Macfarlane said in a statement. “Though the U.K. is part of a separate licensing process in Europe and there is still a long way to go, the FDA decision is a cause for optimism. The MS Trust will keep watching how things are developing here and provide updates when we can. We are well aware how important this new medicine could be for people with PPMS.”
Her colleague at the MS Society — Genevieve Edwards, director of External Affairs — expressed a similar view in a society update.
“It’s brilliant news that ocrelizumab has been approved for both relapsing and primary progressive MS in the US. We now want to see the European Medicines Agency making the same decision – we’re due to hear in the autumn,” Edwards said. “More than 100,000 people are living with MS in the UK and this drug offers a lot of hope for many of them. It’s particularly exciting for people with the primary progressive form of MS who have no treatment options available to them”
MS Research Australia, an organization working toward “Freedom from MS,” also kept its cheers on hold.
Its update following Ocrevus’ FDA approval echoed their U.K. colleagues’ statement. In Australia, Ocrevus first needs to go through a review by the Therapeutic Goods Administration (TGA) — that country’s equivalent of FDA — and then an assessment by the Pharmaceutical Benefits Advisory Committee, which looks into a drug’s cost-effectiveness compared to other treatments.
Only then will it be known if, and for which patients, Ocrevus will be available in Australia.
“MS is a very varied disease, and not all medications will work for all people. However, the addition of another weapon in the arsenal is very promising and the fact this is the first medication for primary progressive MS is exciting,” MS Research Australia wrote.
The German Multiple Sclerosis Society Federation along with the Esclerosis Múltiple España — the Spanish MS organization — each posted brief updates of the approval, only stating that more information will follow.
So it appears that while the FDA decision sparked hope of approvals elsewhere, for patients outside the U.S., the wait for final word on Ocrevus continues.