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Biogen's (BIIB) Alzheimer's Disease Drug Gets FDA Fast Track Tag

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Biogen (BIIB - Free Report) and partner Eisai announced that the FDA granted a Fast Track designation to its anti-amyloid beta protofibril antibody candidate lecanemab for the treatment of early Alzheimer’s disease (AD).

Fast Track is designed to facilitate development and acceleration of the review of drugs to treat serious conditions and fill an unmet medical need or offer a potential advantage over the existing treatments.

Lecanemab was also granted a Breakthrough Therapy status in June 2021 by the FDA for AD.

Earlier in September, Eisai initiated a rolling submission of a biologics license application (BLA), seeking approval for lecanemab in the given indication under an accelerated pathway. The BLA is supported by data from a phase IIb study (Study 201). Data from the study showed that treatment with the candidate led to a high degree of decline in amyloid beta plaque, a key criterion to measure disease improvement in AD patients. The study outcomes also demonstrated that treatment with lecanemab resulted in a consistent reduction of clinical decline across several clinical endpoints.

A phase III Clarity AD study is evaluating lecanemab in early AD patients. The study completed enrolment earlier this year in March and will serve as a confirmatory study for lecanemab when it will seek full approval from the FDA.

Biogen is also evaluating the efficacy of treatment with lecanemab in the phase III AHEAD 3-45 study in two groups of particpants, one with preclinical AD and elevated amyloid and the other with early preclinical AD and intermediate amyloid.

Shares of Biogen have dipped 3.9% so far this year compared with the industry’s 20% decline.

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Biogen’s another AD drug Aduhelm received an accelerated approval from the FDA this year in June to treat patients with mild cognitive impairment or mild dementia due to AD.

Despite being the first medicine to be approved for reducing the clinical decline in AD indication, the launch of Aduhelm has been slow so far due to limited patient access amid a lack of clarity on Aduhelm reimbursement.

The launch of the drug has been slower than expected as patient access is limited, pending the CMS reimbursement decision. The final National Coverage Decision (NCD) from the CMS for the class of anti-amyloid antibodies like Aduhelm is expected in April.

We remind investors that Aduhelm’s FDA approval faced criticism. Issues like mixed efficacy results of the drug from phase III studies, the FDA nod despite the FDA advisory committee voting against its approval and its hefty price tag of $56,000 per year seemingly affected demand, patient access and the reimbursement for Aduhelm. In fact, the product recorded sales of $0.3 million for third-quarter 2021, which was lower than expected.

To improve patient access, Biogen had announced earlier this week that it is lowering the price of wholesale acquisition cost (WAC) of Aduhelm by approximately 50%, effective Jan 1, 2022.

Despite all the criticisms, Aduhelm put a spotlight on AD. Pharmaceutical giants like Roche (RHHBY - Free Report) and Eli Lilly (LLY - Free Report) also developed their own AD candidates, which show potential.

Gantenerumab, Roche’s pipeline candidate for AD, is an anti-amyloid beta antibody developed for subcutaneous administration. In October 2021, Roche announced that the FDA granted a Breakthrough Therapy Designation to gantenerumab, based on data showing that the candidate significantly reduced brain amyloid plaque in the ongoing SCarletRoAD and Marguerite RoAD open-label extension studies as well as other studies.

Eli Lilly developed donanemab, an investigational antibody therapy for AD. Lilly's phase II study TRAILBLAZER-ALZ investigated the efficacy and safety of donanemab in patients with early symptomatic AD.

Lilly has already initiated a rolling submission with the FDA, seeking an approval for donanemab under the accelerated approval pathway, based on data from TRAILBLAZER-ALZ. Lilly expects to complete this rolling submission by the end of first-quarter 2022.

Zacks Rank & Stock to Consider

Biogen currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the same sector is Repligen (RGEN - Free Report) , which sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Repligen’s earnings per share estimates for 2021 have increased from $2.76 to $2.90 in the past 60 days. The same for 2022 has increased from $3.03 to $3.21 in the past 60 days. Shares of Repligen have risen 38.1% in the year so far.

Earnings of Repligen beat estimates in all the last four quarters, the average being 49.2%.

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