First treatment for form of MS approved by FDA
pharmafile | March 30, 2017 | News story | Sales and Marketing | Biogen, Genentech, MS, Roche
In big news for sufferers of MS and the company that developed the drug, Roche subsidiary Genetech, the FDA has approved Ocrevus for primary progressive multiple sclerosis (PPMS) and relapsing forms of MS (RMS). The treatment comes as the first new treatment for those suffering from the rare form of MS, PPMS.
The approval has been met by a big reaction from both the industry and MS sufferers, yet it has not been an easy ride getting the drug to approval. From the first experiments to prove that the human body’s B cells played a role in the development of MS, there has been 20 year wait for those with PPMS to receive an FDA-approved treatment.
Even when Roche had applied to the FDA, the road to approval was not a smooth one – with the drug getting knocked by the FDA, in December of last year, due to manufacturing issues. This resulted in a further three months delay before its final approval.
The eventual approval comes is significant because of the benefits of the drug,, with patients in trials of RMS finding a 46% reduction in the annualised relapse rate and those with PPMS displaying a 24% relative risk reduction in confirmed disability progression.
The entry onto the market of Ocrevus is going to change the MS treatment field, as it stands. A key point to be raised on the drug is the price at which the drug will be marketed – coming in at $65,000 per year. There’s no question this is expensive but it does undercut Merck KGaA’s Rebif, a rival, by 25% and also comes in cheaper than other rival treatments.
Aside from price, the drug offers a safety profile that will be the envy of others in the field. Current issues with the drug are limited to infusion-site infections and mild or moderate airway infections.
“The FDA’s approval of Ocrevus is the beginning of a new era for the MS community and represents a significant scientific advance with this first-in-class B cell targeted therapy,” said Sandra Horning, Chief Medical Officer and Head of Global Product Development. “Until now, no FDA-approved treatment has been available to the primary progressive MS community, and some people with relapsing forms of MS continue to experience disease activity and disability progression despite available therapies. We believe Ocrevus, given every six months, has the potential to change the disease course for people with MS, and we are committed to helping those who can benefit gain access to our medicine.”
As mentioned by Horning, it will change MS market entirely – especially given the method of treatment, which is every six months and does not require the daily oral medication or more regular intravenous infusions of rivals.
Biogen, which has its own rival treatments (Tysabri and Tecfidera), will stand to suffer and gain from the approval. Though its own treatment will lose a chunk of their market share, it will also gain from a 13% to 24% royalty on sales of the drug, in the US.
Experts predict that the drug could bring in potential peak sales of $4 billion by 2022.
Ben Hargreaves
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