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Biogen (BIIB) Stock Down Despite FDA Nod to Alzheimer's Drug
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Biogen’s (BIIB - Free Report) stock was down on Friday despite FDA’s long-awaited full approval to its and partner Eisai’s Alzheimer’s disease (AD) drug, Leqembi.
On Thursday, the FDA had granted traditional approval to Biogen and partner Eisai’s Leqembi, an anti-amyloid beta protofibril antibody drug, for the treatment of AD. It was a huge milestone for the companies as it was the first Alzheimer’s drug to get traditional approval from the FDA.
Leqembi is the first and only approved Alzheimer’s treatment that has reduced the rate of disease progression and slowed down cognitive and functional decline in adults with AD in clinical studies.
However, stocks of Biogen and Eisai declined on the news. Biogen’s stock was down 3.5%. Eisai’s stock declined 1.67%.
Biogen’s stock has risen 0.6% this year so far against a decrease of 12% for the industry.
Image Source: Zacks Investment Research
The FDA had granted accelerated approval to Leqembi in January. However, the drug was not expected to contribute much to revenues until the Centers for Medicare & Medicaid Services (CMS) granted reimbursement for it under Medicare plans. Once Leqembi received traditional approval, the CMS also announced broader Medicare coverage for the same. A broad range of patients can get access to Leqembi following CMS’ decision.
However, the label of the drug included some warnings about bleeding and swelling in the brain. Leqembi’s label has a box warning about amyloid-related imaging abnormalities (ARIA), particularly in ApoE4 homozygous patients, related to monoclonal antibodies directed against aggregated forms of amyloid beta, including Leqembi. Meanwhile, CMS has also released a registry, including a data submission process that requires doctors to submit required patient data to CMS. The registry is to ensure that patients are being monitored in the real world.
These were some of the reasons why the stocks were down despite FDA’s full approval and broad CMS reimbursement.
Eisai had submitted the supplemental biologics license application (sBLA) seeking traditional approval to the FDA the same day it received the accelerated approval.
The FDA approval was based on positive data from the CLARITY AD study, which achieved its primary endpoint of reduction in Clinical Dementia Rating-Sum of Boxes (“CDR-SB”) scale by 27% compared with a placebo. The CDR-SB is a numerical scale that measures the severity of dementia symptoms. The study also achieved statistically significant results for its secondary endpoints.
Eisai leads the clinical development and regulatory submissions of Leqembi. The companies also developed another anti-amyloid antibody, Aduhelm, which was approved by the FDA in June 2021 but failed to generate significant sales.
Several other companies are also developing drugs for Alzheimer’s disease. In January, the FDA issued a complete response letter (CRL) to Eli Lilly’s (LLY - Free Report) BLA seeking accelerated approval for donanemab for the treatment of early symptomatic Alzheimer's disease. The BLA was based on data from the phase II TRAILBLAZER-ALZ study, which showed that donanemab led to amyloid plaque reduction.
However, the FDA rejected the BLA as it believed the accelerated approval submission included data for only a limited number of patients with 12-month drug exposure. The FDA has asked Lilly to include data from at least 100 patients who received a minimum of 12 months of continued treatment with donanemab.
Last month, Lilly announced positive data from the phase III TRAILBLAZER-ALZ 2 study that showed that treatment with donanemab significantly slowed cognitive and functional decline in people with early symptomatic AD. Based on this result, Eli Lilly will start filing regulatory submissions in the coming weeks for the candidate in AD indication, including a regulatory filing with the FDA.
Roche’s (RHHBY - Free Report) phase III GRADUATE I and II studies on a key Alzheimer’s pipeline candidate, gantenerumab failed to meet the primary endpoint of slowing clinical decline in people with early AD in November 2022. The level of beta-amyloid removal by Roche’s gantenerumab was less than expected. Roche developed the candidate in collaboration with MorphoSys.
Image: Bigstock
Biogen (BIIB) Stock Down Despite FDA Nod to Alzheimer's Drug
Biogen’s (BIIB - Free Report) stock was down on Friday despite FDA’s long-awaited full approval to its and partner Eisai’s Alzheimer’s disease (AD) drug, Leqembi.
On Thursday, the FDA had granted traditional approval to Biogen and partner Eisai’s Leqembi, an anti-amyloid beta protofibril antibody drug, for the treatment of AD. It was a huge milestone for the companies as it was the first Alzheimer’s drug to get traditional approval from the FDA.
Leqembi is the first and only approved Alzheimer’s treatment that has reduced the rate of disease progression and slowed down cognitive and functional decline in adults with AD in clinical studies.
However, stocks of Biogen and Eisai declined on the news. Biogen’s stock was down 3.5%. Eisai’s stock declined 1.67%.
Biogen’s stock has risen 0.6% this year so far against a decrease of 12% for the industry.
Image Source: Zacks Investment Research
The FDA had granted accelerated approval to Leqembi in January. However, the drug was not expected to contribute much to revenues until the Centers for Medicare & Medicaid Services (CMS) granted reimbursement for it under Medicare plans. Once Leqembi received traditional approval, the CMS also announced broader Medicare coverage for the same. A broad range of patients can get access to Leqembi following CMS’ decision.
However, the label of the drug included some warnings about bleeding and swelling in the brain. Leqembi’s label has a box warning about amyloid-related imaging abnormalities (ARIA), particularly in ApoE4 homozygous patients, related to monoclonal antibodies directed against aggregated forms of amyloid beta, including Leqembi. Meanwhile, CMS has also released a registry, including a data submission process that requires doctors to submit required patient data to CMS. The registry is to ensure that patients are being monitored in the real world.
These were some of the reasons why the stocks were down despite FDA’s full approval and broad CMS reimbursement.
Eisai had submitted the supplemental biologics license application (sBLA) seeking traditional approval to the FDA the same day it received the accelerated approval.
The FDA approval was based on positive data from the CLARITY AD study, which achieved its primary endpoint of reduction in Clinical Dementia Rating-Sum of Boxes (“CDR-SB”) scale by 27% compared with a placebo. The CDR-SB is a numerical scale that measures the severity of dementia symptoms. The study also achieved statistically significant results for its secondary endpoints.
Eisai leads the clinical development and regulatory submissions of Leqembi. The companies also developed another anti-amyloid antibody, Aduhelm, which was approved by the FDA in June 2021 but failed to generate significant sales.
Several other companies are also developing drugs for Alzheimer’s disease. In January, the FDA issued a complete response letter (CRL) to Eli Lilly’s (LLY - Free Report) BLA seeking accelerated approval for donanemab for the treatment of early symptomatic Alzheimer's disease. The BLA was based on data from the phase II TRAILBLAZER-ALZ study, which showed that donanemab led to amyloid plaque reduction.
However, the FDA rejected the BLA as it believed the accelerated approval submission included data for only a limited number of patients with 12-month drug exposure. The FDA has asked Lilly to include data from at least 100 patients who received a minimum of 12 months of continued treatment with donanemab.
Last month, Lilly announced positive data from the phase III TRAILBLAZER-ALZ 2 study that showed that treatment with donanemab significantly slowed cognitive and functional decline in people with early symptomatic AD. Based on this result, Eli Lilly will start filing regulatory submissions in the coming weeks for the candidate in AD indication, including a regulatory filing with the FDA.
Roche’s (RHHBY - Free Report) phase III GRADUATE I and II studies on a key Alzheimer’s pipeline candidate, gantenerumab failed to meet the primary endpoint of slowing clinical decline in people with early AD in November 2022. The level of beta-amyloid removal by Roche’s gantenerumab was less than expected. Roche developed the candidate in collaboration with MorphoSys.
Zacks Rank
Biogen currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.