Biogen BIIB announced that the FDA has accepted the supplemental biologics license application (sBLA) filed by partner Eisai. The sBLA seeks traditional approval for their newly approved drug Leqembi for treating early Alzheimer’s disease. The FDA also granted priority review designation to the sBLA with a decision expected on Jul 6, 2023
The FDA had granted accelerated approval to Leqembi, an anti-amyloid beta protofibril antibody drug, in January. Eisai submitted the sBLA to the FDA for traditional approval of Leqembi the same day it received the accelerated approval.
The sBLA was based on data from the large phase III confirmatory study, Clarity AD, on lecanemab, which showed that treatment with lecanemab in the early stages of the disease reduced the rate of clinical decline on the CDR-SB scale by 27% compared to placebo. Clinical Dementia Rating-Sum of Boxes or CDR-SB is a numerical scale that measures the severity of symptoms of dementia. The FDA will study the Clarity AD data to determine whether to convert the accelerated approval of Leqembi to a traditional approval
We remind investors that the accelerated approval was based on data from a phase II study (Study 201), which showed that treatment with lecanemab reduced the accumulation of amyloid beta (Aβ) plaque in the brain. Aβ plaque is a lesion in the brain that defines the neuropathological diagnosis of Alzheimer's disease. Lecanemab is one of the several drugs, which aim to remove these plaques from the brain of Alzheimer’s patients.
Biogen’s stock has risen 31.4% in the past year against a decline of 5.6% for the industry.
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Biogen has developed lecanemab in collaboration with Eisai, with the latter leading the clinical development and regulatory submissions. Eisai and Biogen will co-commercialize and co-promote the drug. The companies also developed another anti-amyloid antibody, Aduhelm, which was approved by the FDA in June 2021 but failed to generate meaningful sales.
Some other large-cap pharma giants like Roche RHHBY and Eli Lilly LLY are also developing beta amyloid-targeting drugs for the AD indication.
The FDA issued a complete response letter (CRL) to Eli Lilly’s BLA seeking accelerated approval of 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.
The FDA rejected the BLA as it believes that the accelerated approval submission includes 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.
Despite the CRL, Lilly still expects top-line data readout from the confirmatory phase III TRAILBLAZER-ALZ 2 study in the second quarter of 2023, which, if positive, will form the basis of its application for traditional regulatory approval.
Roche’s 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 Alzheimer’s disease in November 2022. The level of beta-amyloid removal by gantenerumab was less than expected. Roche developed the candidate in collaboration with MorphoSys.
Zacks Rank & Stock to Consider
Biogen has a Zacks Rank #3 (Hold) currently. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
A better-ranked biotech stock is eFFECTOR Therapeutics EFTR, which has Zacks Rank #1.
Loss estimates for eFFECTOR Therapeutics for 2023 have narrowed from 96 cents to 88 cents in the past 60 days.
Earnings of eFFECTOR Therapeutics beat estimates in each of the trailing four quarters. The average earnings surprise for EFTR is 104.56%. EFTR stock has declined 87.3% in the past year. eFFECTOR Therapeutics is expected to report its fourth-quarter results soon.
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