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Biogen (BIIB), Eisai's Lecanemab Gets FDA Nod for Alzheimer's
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Biogen (BIIB - Free Report) announced that the FDA has granted accelerated approval to it and partner Eisai’s anti-amyloid beta protofibril antibody candidate lecanemab to treat early Alzheimer’s disease (early AD).
The drug will be marketed by the brand name of Leqembi. Its label mentions that treatment with the drug should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical studies.
The accelerated approval is 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. Eisai has priced Leqembi at a wholesale acquisition cost (WAC) of $26,500 per year.
Last year, Biogen presented data from their 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.
Biogen’s shares were up about 2.8% on Jan 6, following the news. Biogen’s stock has risen 18.7% in the past year against a decrease of 16.6% for the industry.
Image Source: Zacks Investment Research
Based on data from this study, Eisai also filed a supplemental biologics license application (sBLA) to the FDA to get a traditional approval of Leqembi. Eisai plans to file for marketing authorization applications of lecanemab in Japan and EU by March 2023.
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.
Aduhelm’s FDA approval in June 2021 faced a lot of criticism about its mixed efficacy results, the FDA selection of the accelerated approval path and the regulatory process in general. The FDA approved Aduhelm despite an FDA advisory committee voting against its approval due to mixed outcomes data from ENGAGE and EMERGE phase III studies. All these issues affected demand, patient access and reimbursement for Aduhelm, which resulted in slow launch.
The Centers for Medicare & Medicaid Services (“CMS”) in its final National Coverage Determination (NCD) decision said it will cover FDA-approved drugs like Aduhelm only for patients enrolled in CMS-approved studies, basically denying broad reimbursement. The NCD decision reduced Aduhelm’s demand to a minimal level.
It remains to be seen if Leqembi can compensate for the controversial approval of Aduhelm. The CMS will now give its decision whether it will reimburse patients for the cost of Leqembi. If reimbursed, Leqembi has the potential to generate blockbuster sales.
Some other large-cap pharma giants like Roche (RHHBY - Free Report) and Eli Lilly (LLY - Free Report) are also developing beta amyloid-targeting drugs for the AD indication. The Alzheimer’s candidates of these companies are in late-stage development or review and are expected to be launched in a few months.
Eli Lilly’s BLA seeking accelerated approval of donanemab, based on data from the TRAILBLAZER-ALZ study, is already under review with the FDA. A decision is expected in early 2023. Lilly also expects a data readout from the phase III TRAILBLAZER-ALZ 2 by mid-2023, which, if positive, will form the basis of its application for traditional regulatory approval for donanemab.
Roche’s phase III GRADUATE I and II studies on 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 was developing the candidate in collaboration with MorphoSys.
A better-ranked large drugmaker is Anika Therapeutics (ANIK - Free Report) , which has Zacks Rank #1.
In the past 60 days, estimates for Anika Therapeutics’ 2022 loss per share have narrowed from 75 cents to 69 cents. During the same period, loss estimates per share for 2023 have narrowed from 70 cents to 52 cents. Shares of Anika Therapeutics have declined 12.1% in the past year.
Earnings of Anika Therapeutics beat estimates in two of the last three quarters and missed the mark once, delivering a three-quarter earnings surprise of 12.58%, on average.
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Biogen (BIIB), Eisai's Lecanemab Gets FDA Nod for Alzheimer's
Biogen (BIIB - Free Report) announced that the FDA has granted accelerated approval to it and partner Eisai’s anti-amyloid beta protofibril antibody candidate lecanemab to treat early Alzheimer’s disease (early AD).
The drug will be marketed by the brand name of Leqembi. Its label mentions that treatment with the drug should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical studies.
The accelerated approval is 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. Eisai has priced Leqembi at a wholesale acquisition cost (WAC) of $26,500 per year.
Last year, Biogen presented data from their 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.
Biogen’s shares were up about 2.8% on Jan 6, following the news. Biogen’s stock has risen 18.7% in the past year against a decrease of 16.6% for the industry.
Image Source: Zacks Investment Research
Based on data from this study, Eisai also filed a supplemental biologics license application (sBLA) to the FDA to get a traditional approval of Leqembi. Eisai plans to file for marketing authorization applications of lecanemab in Japan and EU by March 2023.
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.
Aduhelm’s FDA approval in June 2021 faced a lot of criticism about its mixed efficacy results, the FDA selection of the accelerated approval path and the regulatory process in general. The FDA approved Aduhelm despite an FDA advisory committee voting against its approval due to mixed outcomes data from ENGAGE and EMERGE phase III studies. All these issues affected demand, patient access and reimbursement for Aduhelm, which resulted in slow launch.
The Centers for Medicare & Medicaid Services (“CMS”) in its final National Coverage Determination (NCD) decision said it will cover FDA-approved drugs like Aduhelm only for patients enrolled in CMS-approved studies, basically denying broad reimbursement. The NCD decision reduced Aduhelm’s demand to a minimal level.
It remains to be seen if Leqembi can compensate for the controversial approval of Aduhelm. The CMS will now give its decision whether it will reimburse patients for the cost of Leqembi. If reimbursed, Leqembi has the potential to generate blockbuster sales.
Some other large-cap pharma giants like Roche (RHHBY - Free Report) and Eli Lilly (LLY - Free Report) are also developing beta amyloid-targeting drugs for the AD indication. The Alzheimer’s candidates of these companies are in late-stage development or review and are expected to be launched in a few months.
Eli Lilly’s BLA seeking accelerated approval of donanemab, based on data from the TRAILBLAZER-ALZ study, is already under review with the FDA. A decision is expected in early 2023. Lilly also expects a data readout from the phase III TRAILBLAZER-ALZ 2 by mid-2023, which, if positive, will form the basis of its application for traditional regulatory approval for donanemab.
Roche’s phase III GRADUATE I and II studies on 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 was developing 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 large drugmaker is Anika Therapeutics (ANIK - Free Report) , which has Zacks Rank #1.
In the past 60 days, estimates for Anika Therapeutics’ 2022 loss per share have narrowed from 75 cents to 69 cents. During the same period, loss estimates per share for 2023 have narrowed from 70 cents to 52 cents. Shares of Anika Therapeutics have declined 12.1% in the past year.
Earnings of Anika Therapeutics beat estimates in two of the last three quarters and missed the mark once, delivering a three-quarter earnings surprise of 12.58%, on average.