Post by icemandios on Sept 23, 2021 18:28:51 GMT
September 23, 2021 11:17 AM EDT PharmaFDA+
Following controversial Aduhelm approval, DC-based neurology center bans Biogen representatives from its offices — report
Nicole DeFeudis
Editor
CEO Michael Vounatsos confessed earlier this month that Biogen was struggling to get its controversial new Alzheimer’s drug Aduhelm off the ground, with some major health systems refusing to administer it.
Now, a DC-based medical center is taking its small rebellion against the drug’s approval one step further.
The Neurology Center has reportedly banned all Biogen representatives from its seven DC-area offices, according to a photo circulating on Twitter.
So $biib things are looking good for your launch it seems. pic.twitter.com/30ncs5bL3D
— BIO NEWMAN (@lblegend33) September 21, 2021
“In response to the growing controversy over the new Biogen Alzheimer’s medication, Aduhelm, Biogen pharmaceutical representatives are no longer welcome in our offices,” a sign in the photo reads. Fierce Pharma first confirmed the ban with a Neurology Center spokesperson, and Endpoints News has reached out for comment. We will update the story as it develops.
The announcement is the latest reported bump in the road for Aduhelm, whose accelerated approval — and $56,000 price tag — have triggered intense criticism and multiple federal investigations. The drug was approved in June despite an advisory committee’s near-unanimous vote against it, leading three adcomm members to resign in protest.
The approval was based on data that showed Aduhelm could clear beta-amyloid — a sticky plaque that accumulates in patients’ brains, the removal of which was once considered a promising path toward slowing or curing Alzheimer’s. Back in June, CDER director Patrizia Cavazzoni said data showing Aduhelm’s ability to clear amyloid meant it was “reasonably likely” to slow patients’ decline. But prior to Biogen’s conflicting studies, numerous trials for other amyloid-clearing drugs from major drugmakers showed no effect on cognition.
Multiple federal investigations have been launched to evaluate Aduhelm’s approval, cost and the FDA’s cozy relationship with Biogen — including by the HHS Inspector General and the FDA, which is conducting an internal probe.
It could be nine years before Biogen wraps up its confirmatory trial to verify if Aduhelm works as billed. In the meantime, swirling skepticism leaves some physicians hesitant to prescribe the drug to patients. Some centers like the Cleveland Clinic and Mount Sinai have refused to administer Aduhelm altogether, and the Neurology Center has joined that list.
In a statement on the company’s website, the Neurology Center says it’s waiting for questions surrounding the drug’s efficacy and price to be clarified before prescribing it.
Alisha Alaimo, president of Biogen’s US operations, said earlier this month that only about 50 sites so far have begun Aduhelm infusions. But an anonymous employee told Endpoints that 50 seems like an inflated number.
An unnamed source also told STAT earlier this week that just over 100 patients with Alzheimer’s had been infused with Aduhelm as of Sept. 11, and that the slow rollout has Biogen considering cost-cutting measures, including layoffs.
“There is clearly too much confusion, misinformation and controversy surrounding our data and the approval process,” Vounatsos said at a JP Morgan health care conference.
In a note to investors on Wednesday, Mizuho’s Salim Syed said this is the first time he’s seen a major practice ban a pharma company’s reps altogether.
“This is interesting, because Biogen reps aren’t just Aduhelm reps and Biogen is still a major CNS company by really any standard,” he wrote.
When asked to comment on the Neurology Center ban, a Biogen spokesperson responded:
“Patients and their families deserve to have choice and access to FDA approved treatments, including the only Alzheimer’s disease treatment that addresses a defining pathology of the disease. We encourage any patient who is denied access to care to contact us for help, as we remain committed to supporting access to Aduhelm for all appropriate patients.”
Following controversial Aduhelm approval, DC-based neurology center bans Biogen representatives from its offices — report
Nicole DeFeudis
Editor
CEO Michael Vounatsos confessed earlier this month that Biogen was struggling to get its controversial new Alzheimer’s drug Aduhelm off the ground, with some major health systems refusing to administer it.
Now, a DC-based medical center is taking its small rebellion against the drug’s approval one step further.
The Neurology Center has reportedly banned all Biogen representatives from its seven DC-area offices, according to a photo circulating on Twitter.
So $biib things are looking good for your launch it seems. pic.twitter.com/30ncs5bL3D
— BIO NEWMAN (@lblegend33) September 21, 2021
“In response to the growing controversy over the new Biogen Alzheimer’s medication, Aduhelm, Biogen pharmaceutical representatives are no longer welcome in our offices,” a sign in the photo reads. Fierce Pharma first confirmed the ban with a Neurology Center spokesperson, and Endpoints News has reached out for comment. We will update the story as it develops.
The announcement is the latest reported bump in the road for Aduhelm, whose accelerated approval — and $56,000 price tag — have triggered intense criticism and multiple federal investigations. The drug was approved in June despite an advisory committee’s near-unanimous vote against it, leading three adcomm members to resign in protest.
The approval was based on data that showed Aduhelm could clear beta-amyloid — a sticky plaque that accumulates in patients’ brains, the removal of which was once considered a promising path toward slowing or curing Alzheimer’s. Back in June, CDER director Patrizia Cavazzoni said data showing Aduhelm’s ability to clear amyloid meant it was “reasonably likely” to slow patients’ decline. But prior to Biogen’s conflicting studies, numerous trials for other amyloid-clearing drugs from major drugmakers showed no effect on cognition.
Multiple federal investigations have been launched to evaluate Aduhelm’s approval, cost and the FDA’s cozy relationship with Biogen — including by the HHS Inspector General and the FDA, which is conducting an internal probe.
It could be nine years before Biogen wraps up its confirmatory trial to verify if Aduhelm works as billed. In the meantime, swirling skepticism leaves some physicians hesitant to prescribe the drug to patients. Some centers like the Cleveland Clinic and Mount Sinai have refused to administer Aduhelm altogether, and the Neurology Center has joined that list.
In a statement on the company’s website, the Neurology Center says it’s waiting for questions surrounding the drug’s efficacy and price to be clarified before prescribing it.
Alisha Alaimo, president of Biogen’s US operations, said earlier this month that only about 50 sites so far have begun Aduhelm infusions. But an anonymous employee told Endpoints that 50 seems like an inflated number.
An unnamed source also told STAT earlier this week that just over 100 patients with Alzheimer’s had been infused with Aduhelm as of Sept. 11, and that the slow rollout has Biogen considering cost-cutting measures, including layoffs.
“There is clearly too much confusion, misinformation and controversy surrounding our data and the approval process,” Vounatsos said at a JP Morgan health care conference.
In a note to investors on Wednesday, Mizuho’s Salim Syed said this is the first time he’s seen a major practice ban a pharma company’s reps altogether.
“This is interesting, because Biogen reps aren’t just Aduhelm reps and Biogen is still a major CNS company by really any standard,” he wrote.
When asked to comment on the Neurology Center ban, a Biogen spokesperson responded:
“Patients and their families deserve to have choice and access to FDA approved treatments, including the only Alzheimer’s disease treatment that addresses a defining pathology of the disease. We encourage any patient who is denied access to care to contact us for help, as we remain committed to supporting access to Aduhelm for all appropriate patients.”