Biogen Wins FDA Approval for Subcutaneous Starter Dose of Leqembi

Shares of Biogen BIIB rose nearly 5% yesterday after the company announced that the FDA approved a subcutaneous (SC) autoinjector version of Leqembi as an initiation dosing option for the treatment of early Alzheimer’s disease (AD). The SC version of the drug is marketed under the brand name Leqembi Iqlik.

Previously, patients initiating Leqembi therapy were required to receive intravenous (IV) infusions once every two weeks for 18 months before transitioning to monthly IV maintenance dosing or weekly SC maintenance dosing. With the latest approval, patients now start treatment with a once-weekly SC autoinjector, eliminating the need for biweekly IV infusions during the initiation phase.

The new option provides relief to AD patients taking Leqembi, as IV administrations are time-consuming, nearly one hour for each infusion. According to Biogen, this SC version can be administered in about 15 seconds and can even be used by patients at home or in medical centers. Patients may also switch from IV to SC administration or vice versa, providing greater convenience and flexibility in Leqembi administration.

BIIB’s Stock Performance

The latest approval marks an important milestone for Leqembi, as patients can now receive the entire course of treatment through the SC formulation, including at-home administration, if appropriate. While Leqembi Iqlik requires weekly administration, it can be delivered in about 15 seconds using an autoinjector, offering a more convenient alternative to hour-long IV infusions. Investors likely cheered the approval, driving Biogen's shares higher.

Year to date, the stock has risen 19% compared with the industry’s 2% growth.

Image Source: Zacks Investment Research

More on BIIB’s Leqembi

The latest FDA approval is supported by data from multiple clinical studies, which indicated that weekly dosing with Leqembi Iqlik achieved drug exposure equivalent to that of the IV version. Biogen plans to commercially launch this version by the end of next month.

Leqembi was initially approved by the FDA in 2023 as a biweekly IV medication (for both initial and maintenance dosing) to treat AD patients with mild cognitive impairment (MCI) or the mild dementia stage of the disease (collectively referred to as ‘early AD’). The drug is approved for a similar indication in the European Union.

Biogen has developed Leqembi in collaboration with Japan-based Eisai, with the latter leading the clinical development and regulatory submissions. Though both companies co-commercialize and co-promote the drug, Eisai has the final decision-making authority.

Biogen Bets on Tau in Next Phase of AD Drug Development

Leqembi is an amyloid-targeting therapy designed to slow disease progression by removing amyloid-beta plaques. Another approved amyloid-targeting AD treatment is Eli Lilly's LLY Kisunla, which poses significant competition to the Biogen/Eisai drug. Both companies are exploring additional disease mechanisms that could further improve AD patient outcomes.

Recently, Biogen made headlines after deciding to advance its experimental tau-targeting therapy, diranersen, into late-stage development despite the candidate missing the primary endpoint in a mid-stage study. Although the study did not demonstrate the expected dose-dependent clinical benefit, pre-specified analyses of cognitive endpoints showed a reduction in clinical decline across all studied doses, particularly among participants receiving the lowest drug dose. The drug is being developed in collaboration with Ionis Pharmaceuticals IONS.

Diranersen remains among the more advanced tau-targeting therapies currently in development for AD, an area that many researchers believe could complement existing amyloid-focused treatments or potentially provide improved disease-modifying benefits.

Biogen Inc. Price

Biogen Inc. price | Biogen Inc. Quote

BIIB’s Zacks Rank

Biogen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Beyond Nvidia: AI's Second Wave Is Here

The AI revolution has already minted millionaires. But the stocks everyone knows about aren't likely to keep delivering the biggest profits. AI’s second wave is moving from infrastructure to implementation and these companies are at the forefront of this transition, positioned to become what Amazon and Google were to the internet era.

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

This article originally published on Zacks Investment Research (zacks.com).

Zacks Investment Research