Biogen (BIIB) still appears likely to secure approval for the subcutaneous induction version of Alzheimer's drug "Leqembi" despite a delayed US Food and Drug Administration review, with recent regulatory precedents and existing clinical data supporting a favorable outcome, RBC Capital Markets said in a report Thursday.
Regulators may need more time to assess safety aspects of the filing, particularly the risk of Amyloid-Related Imaging Abnormalities-Edema/Effusion, or ARIA-E events, in treatment-naive patients. Still, Leqembi's subcutaneous maintenance version is already approved and the data has effectively been under FDA review for about seven months.
The filing relies on pharmacokinetic and pharmacodynamic, or PK/PD, modeling showing that a 500 mg weekly subcutaneous dose should produce results similar to the approved intravenous version, RBC said, adding that past cases involving non-Chemistry, Manufacturing and Controls FDA review delays have generally resulted in eventual approvals, even though there is no exact precedent for Leqembi's specific situation.
RBC has an outperform rating on Biogen, with a price target of $222.
Shares of Biogen were down more than 5% in Thursday trading.
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