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Biogen (BIIB) to Begin Aduhelm Confirmatory Study in 2022

Biogen (BIIB) expects to start the phase IV post-marketing confirmatory study of Aduhelm for Alzheimer's disease in 2022. It expects to complete the study in four years from the study...

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This story originally appeared on Zacks

Biogen BIIB announced that it aims to submit the final protocols for the phase IV post-marketing confirmatory study of Aduhelm (aducanumab) in Alzheimer’s disease (AD) for review to the FDA next March. The company plans to start screening patients in May 2022.

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The study is a post-marketing requirement of the FDA’s accelerated approval of Aduhelm in June 2021. The purpose of the confirmatory study is to convert the accelerated approval to full approval. Aduhelm received accelerated approval from the FDA for the treatment of patients with mild cognitive impairment or mild dementia due to AD.

We note that the accelerated approval was based on data from phase III studies — EMERGE and ENGAGE —  in patients with early-stage AD. Data from these studies showed that Aduhelm reduced amyloid beta plaques by 59-71% at 18 months of treatment. A reduction in amyloid beta plaques is likely to result in a reduction in the clinical decline in AD patients.

The phase IV study is a global study that aims to enroll more than 1300 patients with early AD, with a primary clinical endpoint at 18 months after treatment initiation. Biogen expects to complete the study in approximately four years after initiation, approximately half of the time provided by the FDA as part of the accelerated approval. The study will also include a long-term extension to gather treatment data for up to 48 months.

Biogen’s shares have declined 3.8% so far this year in comparison with the industry’s 20.3% decline.

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Last month, Biogen announced new data from a pre-specified analysis of EMERGE and ENGAGE studies on Aduhelm in AD patients. Data from both the studies demonstrated that the drug achieved a significant reduction in plasma p-tau181, a biomarker of the hallmark tau tangles in AD in a dose- and time-dependent manner versus placebo. This reduction in plasma p-tau demonstrated a statistically significant correlation with reduced cognitive and function decline in AD patients.

Despite being the first medicine to be approved for reducing the clinical decline in AD indication and targeting the underlying cause of the disease, Aduhelm has had a slower-than-expected launch. The drug’s FDA approval faced a lot of criticism regarding its mixed efficacy results. The FDA approved Aduhelm despite an FDA advisory committee voting against its approval last year due to mixed outcomes data from the ENGAGE and EMERGE studies. In fact, the drug also comes with a hefty price tag of $56,000 a year, which was widely condemned. These issues have seemingly affected demand, patient access and reimbursement for Aduhelm. The drug recorded sales of $0.3 million for third-quarter 2021, which was lower than expected.

Aduhelm is not yet approved in Europe.

Biogen issued a press release on Friday announcing that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the marketing authorization application seeking approval for aducanumab in AD. The company will seek re-examination of the negative opinion by the CHMP.

While Aduhelm has garnered several negative headlines, it has also put a spotlight on AD since its controversial approval. Bigwig companies like Roche RHHBY and Eli Lilly LLY, which have developed their own AD candidates, show promise.

Roche’s pipeline candidate for AD, gantenerumab, is an anti-amyloid beta antibody developed for subcutaneous administration. In October 2021, Roche announced that gantenerumab was granted the Breakthrough Therapy Designation by the FDA based on data that showed 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 has 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 approval for donanemab under the accelerated approval pathway based on data from TRAILBLAZER-ALZ. The rolling submission is expected to be completed 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 IVERIC bio ISEE, which holds a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

IVERIC bio’s loss per share estimates for 2021 have narrowed from $1.18 to $1.09 in the past 60 days. The same for 2022 has narrowed from $1.17 to $1.03 in the past 60 days. Shares of IVERIC bio have gained 114.6% in the year so far.

IVERIC bio’s earnings missed estimates in three of the last four quarters and surpassed expectations once, with the negative surprise being 5.6%, on average.



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