New ARIA cases dog Biogen’s Aduhelm launch in another potential blow to blockbuster hopes — analyst – Endpoints News
https://endpts.com/new-aria-cases-d...in-another-blow-to-blockbuster-hopes-analyst/
New ARIA cases dog Biogen's Aduhelm launch in another potential blow to blockbuster hopes — analyst
Kyle Blankenship
Managing Editor
Perhaps anticipating a walkover with an FDA approval in hand, Biogen has instead faced a wall of pushback over its controversial Alzheimer’s med Aduhelm. With payers and clinics largely staying away, Biogen’s drug is posting some troubling safety signals that could derail the launch even further.
In a note to clients Friday, analysts from Baird revealed new safety data from the FDA’s Adverse Event Reporting System (FAERS) showing a troubling recurrence of ARIA in the early crop of patients who have been dosed with Aduhelm.
According to Baird’s data, which it received as the result of a FOIA request, there have been three reported cases of ARIA to the agency between June 7 and August, all of which required hospitalization, the analysts said. One of those cases was so severe it was described as life-threatening in the agency’s database.
ARIA, or amyloid-related imaging abnormalities, is a hallmark side effect of amyloid-targeted therapies for Alzheimer’s disease and was one sticking point during Aduhelm’s controversial regulatory approval process. The Baird team went out of its way to note that the FAERS system, which doesn’t ascribe causality to any particular side effect, is a notoriously unreliable metric — they called it a “tricky beast” — but the presence of ARIA alone indicates a strong connection to Aduhelm.
The Baird team highlighted the one reported life-threatening case, which involved a 77-year-old woman who experienced ARIA and status epilepticus, or a seizure that lasts five or more minutes. The reported ARIA “establishes … some level of causality for the event,” the analysts opined, and the report of status epilepticus represents an extremely severe side effect that could present a new safety red flag for Aduhelm. The analysts noted the female patient was on multiple other medications at the time.
“We think these additional events reflect a picture of a drug that is far from benign,” the analysts wrote.
A Biogen spokesperson told Endpoints most of the reported safety data in the FAERS database were from patients in the drug’s Phase III trials and EMBARK, a follow-on re-dosing study for aducanumab patients in those late-stage tests. None of the ARIA cases were from commercial patients, the spokesperson said. Biogen went further to say that the FAERS data also include follow-ups from initial patients but didn’t clarify whether that was the case with the ARIA reports.
ARIA has been a stumbling block from the beginning for Aduhelm, with more than a third of patients affected in Biogen’s trials. Biogen has mostly written off the safety flags, saying the risk-benefit profile favors the drug’s efficacy — despite even more questions about whether Aduhelm actually slows cognitive decline — and that ARIA can be managed by physicians. But critics have pointed, in particular, to the administration of Aduhelm in long-term care communities, where ARIA may be caught too late for many patients.
“Amyloid-related imaging abnormalities have been reported in our clinical trials. Our prescribing information provides extensive information to help doctors and patients make informed decisions about benefit-risk and safety monitoring,” a Biogen spokesperson told Endpoints News. “Like any medicine, benefit-risk for medicine needs be considered and we believe in the safety-efficacy profile of Aduhelm.”
These new safety findings come amid a torturous rollout for Aduhelm dogged by pushback from government payers as well as administering clinics. A pending national coverage determination from the Centers for Medicare and Medicaid Services has had trickle-down effects on other payers and prescribers, who are waiting to see how Medicare pans out before making their own determinations on the pricey therapy.
In a report earlier this week, STAT revealed that just over 100 patients have been dosed with Aduhelm since launch, according to a source familiar with the matter, far below the company’s internal estimates and well off pace for the drug’s blockbuster launch plans.
Meanwhile, a second amyloid-clearing drug in Eli Lilly’s donanemab is on track for a Q4 filing of its own, potentially adding even more pressure on Biogen as the new year approaches.
https://endpts.com/new-aria-cases-d...in-another-blow-to-blockbuster-hopes-analyst/
New ARIA cases dog Biogen's Aduhelm launch in another potential blow to blockbuster hopes — analyst
Kyle Blankenship
Managing Editor
Perhaps anticipating a walkover with an FDA approval in hand, Biogen has instead faced a wall of pushback over its controversial Alzheimer’s med Aduhelm. With payers and clinics largely staying away, Biogen’s drug is posting some troubling safety signals that could derail the launch even further.
In a note to clients Friday, analysts from Baird revealed new safety data from the FDA’s Adverse Event Reporting System (FAERS) showing a troubling recurrence of ARIA in the early crop of patients who have been dosed with Aduhelm.
According to Baird’s data, which it received as the result of a FOIA request, there have been three reported cases of ARIA to the agency between June 7 and August, all of which required hospitalization, the analysts said. One of those cases was so severe it was described as life-threatening in the agency’s database.
ARIA, or amyloid-related imaging abnormalities, is a hallmark side effect of amyloid-targeted therapies for Alzheimer’s disease and was one sticking point during Aduhelm’s controversial regulatory approval process. The Baird team went out of its way to note that the FAERS system, which doesn’t ascribe causality to any particular side effect, is a notoriously unreliable metric — they called it a “tricky beast” — but the presence of ARIA alone indicates a strong connection to Aduhelm.
The Baird team highlighted the one reported life-threatening case, which involved a 77-year-old woman who experienced ARIA and status epilepticus, or a seizure that lasts five or more minutes. The reported ARIA “establishes … some level of causality for the event,” the analysts opined, and the report of status epilepticus represents an extremely severe side effect that could present a new safety red flag for Aduhelm. The analysts noted the female patient was on multiple other medications at the time.
“We think these additional events reflect a picture of a drug that is far from benign,” the analysts wrote.
A Biogen spokesperson told Endpoints most of the reported safety data in the FAERS database were from patients in the drug’s Phase III trials and EMBARK, a follow-on re-dosing study for aducanumab patients in those late-stage tests. None of the ARIA cases were from commercial patients, the spokesperson said. Biogen went further to say that the FAERS data also include follow-ups from initial patients but didn’t clarify whether that was the case with the ARIA reports.
ARIA has been a stumbling block from the beginning for Aduhelm, with more than a third of patients affected in Biogen’s trials. Biogen has mostly written off the safety flags, saying the risk-benefit profile favors the drug’s efficacy — despite even more questions about whether Aduhelm actually slows cognitive decline — and that ARIA can be managed by physicians. But critics have pointed, in particular, to the administration of Aduhelm in long-term care communities, where ARIA may be caught too late for many patients.
“Amyloid-related imaging abnormalities have been reported in our clinical trials. Our prescribing information provides extensive information to help doctors and patients make informed decisions about benefit-risk and safety monitoring,” a Biogen spokesperson told Endpoints News. “Like any medicine, benefit-risk for medicine needs be considered and we believe in the safety-efficacy profile of Aduhelm.”
These new safety findings come amid a torturous rollout for Aduhelm dogged by pushback from government payers as well as administering clinics. A pending national coverage determination from the Centers for Medicare and Medicaid Services has had trickle-down effects on other payers and prescribers, who are waiting to see how Medicare pans out before making their own determinations on the pricey therapy.
In a report earlier this week, STAT revealed that just over 100 patients have been dosed with Aduhelm since launch, according to a source familiar with the matter, far below the company’s internal estimates and well off pace for the drug’s blockbuster launch plans.
Meanwhile, a second amyloid-clearing drug in Eli Lilly’s donanemab is on track for a Q4 filing of its own, potentially adding even more pressure on Biogen as the new year approaches.