Post by icemandios on Nov 19, 2021 16:50:24 GMT
November 18, 2021 01:31 PM ESTUpdated 27 minutes ago FDA+
Exclusive: FDA probing death of Aduhelm patient as Biogen's Alzheimer's drug continues to stir controversy
John Carroll
Editor & Founder
Zachary Brennan
Senior Editor
Brian Abrahams
The FDA tells Endpoints News today that itâs aware of the death of a patient taking Biogenâs controversial Alzheimerâs drug Aduhelm (aducanumab) and is âactively investigatingâ the case.
Their statement follows the latest comments from RBC analyst Brian Abrahams, who is back with an update on the death, and this time he says that there are solid reasons to believe that the event was likely drug related and may have been preventable.
A spokesperson for the agency tells Endpoints: âFDA is aware of this case and is actively investigating it.â
Abrahams, a physician, notes that he obtained new information using FOIA, getting the âdetailed case reportâ about the aducanumab patient he was first to report on.
After reviewing the sequence of events, it appears likely to us that progressively severe cerebral edema/ARIA, which led to status epilepticus, was the inciting factor for the ptâs deterioration and ultimate demise, and that this is likely to have been caused by aducanumab.
Thatâs not likely by itself to cause the drug to be yanked out of the market, he adds, but it may well call for more stringent monitoring of patients, something that will add to the already considerable cost of the therapy â as well as the mounting skepticism over its use.
The ptâs specific reaction to this usually benign AE may have been atypical, and there look to have been multiple points at which increased risk could have been recognized and adu either not started or discontinued. These included several findings of asymptomatic ARIA-E and ARIA-H observed in prior years (when the pt was receiving an investigational therapy, perhaps adu) as well as moderate ARIA-E primarily on the left side (the side that worsened) found upon re-examination of an MRI taken a few months prior. We note that according to the present label, ARIA is not necessarily a reason for discontinuation, and âtreatment may be continued with caution.â
Biogen, which acknowledged earlier that it is investigating the death, issued a statement Thursday afternoon saying that Abrahams only has part of the information needed to draw a conclusion, and that theyâre continuing their own probe to assess the cause. The company states:
The RBC report only provides a partial view of the case. As we previously stated, the cause of death is unknown at this time. We know the 75-year-old clinical trial patient was admitted to the hospital with a seizure and diagnosed with cerebral edema thought to be ARIA-E. Following a prolonged hospitalization, the patient was being prepared for discharge when she deteriorated and was transferred to another facility. We have requested missing information, including brain imaging, from the critical last nine days of hospitalization.
If the death is definitively linked to the drug, it will raise fresh fears that the FDA approved a therapeutic that presents a clear threat to patients, without any solid evidence that it could help soften the onset of the memory-wasting disease. So far, the drug has proven an embarrassment to Biogen, which saw sales sputter to a ragged start after the FDAâs approval triggered a storm of controversy as experts denounced the move.
Itâs also bad news for the other manufacturers in the space â like Eli Lilly and Roche â angling to leapfrog Biogen into the market with their own rival drugs, which also are linked to high rates of ARIA. The developers maintain that the bulk of these cases involving brain swelling and bleeds are relatively mild and are easily controlled. Critics, though, wonder how well severe cases can be managed with a drug aimed at a huge population of patients.
This has been a miserable week for Biogen CEO Michel Vounatsos, who first accepted the resignation of the companyâs chief scientist â and primary aducanumab advocate â Al Sandrock, then soon after reported that European regulators had turned thumbs down on an approval, likely wiping out what could have been 40% of their global market.
Exclusive: FDA probing death of Aduhelm patient as Biogen's Alzheimer's drug continues to stir controversy
John Carroll
Editor & Founder
Zachary Brennan
Senior Editor
Brian Abrahams
The FDA tells Endpoints News today that itâs aware of the death of a patient taking Biogenâs controversial Alzheimerâs drug Aduhelm (aducanumab) and is âactively investigatingâ the case.
Their statement follows the latest comments from RBC analyst Brian Abrahams, who is back with an update on the death, and this time he says that there are solid reasons to believe that the event was likely drug related and may have been preventable.
A spokesperson for the agency tells Endpoints: âFDA is aware of this case and is actively investigating it.â
Abrahams, a physician, notes that he obtained new information using FOIA, getting the âdetailed case reportâ about the aducanumab patient he was first to report on.
After reviewing the sequence of events, it appears likely to us that progressively severe cerebral edema/ARIA, which led to status epilepticus, was the inciting factor for the ptâs deterioration and ultimate demise, and that this is likely to have been caused by aducanumab.
Thatâs not likely by itself to cause the drug to be yanked out of the market, he adds, but it may well call for more stringent monitoring of patients, something that will add to the already considerable cost of the therapy â as well as the mounting skepticism over its use.
The ptâs specific reaction to this usually benign AE may have been atypical, and there look to have been multiple points at which increased risk could have been recognized and adu either not started or discontinued. These included several findings of asymptomatic ARIA-E and ARIA-H observed in prior years (when the pt was receiving an investigational therapy, perhaps adu) as well as moderate ARIA-E primarily on the left side (the side that worsened) found upon re-examination of an MRI taken a few months prior. We note that according to the present label, ARIA is not necessarily a reason for discontinuation, and âtreatment may be continued with caution.â
Biogen, which acknowledged earlier that it is investigating the death, issued a statement Thursday afternoon saying that Abrahams only has part of the information needed to draw a conclusion, and that theyâre continuing their own probe to assess the cause. The company states:
The RBC report only provides a partial view of the case. As we previously stated, the cause of death is unknown at this time. We know the 75-year-old clinical trial patient was admitted to the hospital with a seizure and diagnosed with cerebral edema thought to be ARIA-E. Following a prolonged hospitalization, the patient was being prepared for discharge when she deteriorated and was transferred to another facility. We have requested missing information, including brain imaging, from the critical last nine days of hospitalization.
If the death is definitively linked to the drug, it will raise fresh fears that the FDA approved a therapeutic that presents a clear threat to patients, without any solid evidence that it could help soften the onset of the memory-wasting disease. So far, the drug has proven an embarrassment to Biogen, which saw sales sputter to a ragged start after the FDAâs approval triggered a storm of controversy as experts denounced the move.
Itâs also bad news for the other manufacturers in the space â like Eli Lilly and Roche â angling to leapfrog Biogen into the market with their own rival drugs, which also are linked to high rates of ARIA. The developers maintain that the bulk of these cases involving brain swelling and bleeds are relatively mild and are easily controlled. Critics, though, wonder how well severe cases can be managed with a drug aimed at a huge population of patients.
This has been a miserable week for Biogen CEO Michel Vounatsos, who first accepted the resignation of the companyâs chief scientist â and primary aducanumab advocate â Al Sandrock, then soon after reported that European regulators had turned thumbs down on an approval, likely wiping out what could have been 40% of their global market.