The FDA deserves kudos for drawing a line within the sand over their review of Covid-19 vaccines. They’ve made it clear — after deep skepticism began to appear following the debacle over convalescent plasma — simply what they might want to see before handing out an EUA, thus saving the company’s rep for enforcing standards essential to most importanttaining public belief in medicine.
That very same integrity, although, has gone missing from the FDA’s stance on Biogen’s Alzheimer’s drug advertucanumab. Despite a statistical analysis that toplights the conflicting nature of the Biogen $BIIB data, a publish hoc dumpster dive operation to seek out supportive data and a transfer to shine up small cohort results as againup proof of efficacy, the FDA division responsible for Alzheimer’s selected to endorse adu to be used amongst millions of patients.
We’ve been right here before. The Sarepta approval leading to marketing authorization — with a label that clearly states their first, very expensive, Duchenne MD drug remains experimalestal — is a permanent black eye on the subject of indusstrive standards. What followed simply made all of it a lot, a lot worse — and appears to be about able to happen once more in an infinitely larger patient population.
On the time, as I discovered honestly recently, the FDA’s Janet Woodencock repeatedly instructed colleagues that an approval for Sarepta was a once-off decision. She signed off on biomarker data from a tiny examine one time. The subsequent time Sarepta must do somefactor like a stroll take a look at with extra boys. She needed real data.
Only that never happened. What did happen: The FDA regulators in cost undertakeed the biomarker data on dystrophin professionalduction as a low bar for an approval, and as soon as they obtained a naysayer out of the way in which who handed out a CRL for his or her second app, the brand new regulators in cost waved it via.
So we shouldn’t consider this some form of once-off simply to provide Alzheimer’s patients a drug they’ll use until somefactor guesster comes alongside.
It is a precedent that can be utilized many times, lowering the bar on Alzheimer’s data that others can leap over as effectively.
What else did we be taught from Sarepta?
One, whenever you catch a ‘Hail Mary’ cross, there’s no have to do somefactor like actually meet FDA timetraces for a full pivotal trial to conagency the weak indicators of efficacy you’re seeing. The biotech drug their heels on that forobtainedten entrance for years, and the FDA did nothing about it.
We see this form of factor regularly. As soon as a drug wins any type of fast OK, it doesn’t almethods simply disappear as soon as the required Section III followup — inevitably requiring years — seems to be a flop.
An unmet medical want like Alzheimer’s is a terrible factor. However when FDA standards go within the trash bin on the way in which into an advertvisory panel meeting, it hurts eachone — patients and indusstrive alike. In the event you destroy patients’ belief in regulatory decisions, because the FDA appears determined to do right here, you undermine all marketed therapeutics.
We’ll discover out what the FDA panel thinks of advertucanumab later today. Most drug developers alprepared know that the FDA is being pushed by political reasons right here. The science simply doesn’t again it up.