by Professor Gavin Giovannoni
Finally a phase 3 trial in progressive MS is being done outside of Big Pharma. Great news for people with progressive MS. We will now get an answer about whether or not simvastatin works in a larger study, its safety profile and more importantly its risk:benefit profile in people with more advanced MS. This study may give us clues about how simvastatin is working; is it working via comorbidities or specific anti-inflammatory or neuroprotective mechanisms?
Have we learnt our lessons about drug repurposing? If positive will this trial lead to a regulatory submission and label extension for simvastatin? Who will manage the regulatory submission? Who will maintain the license? Will one phase 3 trial be sufficient? Will the regulators want more data on a dose-response? Will a regulatory submission be necessary? If simvastatin goes unlicensed for MS will the wider community adopt it? How will it be used in clinical practice; as a monotherapy or add-on to all other DMTs? How will Pharma respond? All these questions will only need to be answered if the trial is positive; so let’s find out.
Congratulations to Jeremy Chataway and the team who pulled this together. Getting trials like this designed, costed and funded is no easy task, particularly when you see the number of partners. Well done! Pharma must be asking how academia can run trials of this size and complexity so cheaply. May be the Pharma machine has become too complex?
Article originally published on 9 May 2017 on the Barts MS Blog