Eisai seeks PMDA approval for subcutaneous Leqembi in Japan
Eisai has submitted a brand new drug utility looking for approval from Japan’s Prescription drugs and Medical Units Company (PMDA) for Leqembi’s (lecanemab) subcutaneous (SC) formulation (SC-AI) for early Alzheimer’s illness.
The formulation will function a brand new administration route.
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Eisai’s utility relies on information from a number of SC administration sub-studies of lecanemab, performed throughout the Part III Readability AD open-label extension, after the core examine for 18 months in folks with gentle cognitive impairment as a consequence of gentle stage Alzheimers’ dementia.
The research confirmed that once-weekly SC autoinjector SC-AI 500mg administration resulted in equal publicity to intravenous dosing each two weeks, with comparable biomarker and medical outcomes.
The SC route confirmed a security profile similar to intravenous administration, with below 2% of members experiencing systemic injection or infusion-related reactions.
If permitted, sufferers might self-administer the SC-AI 500mg dose (two 250mg injections) at residence as soon as weekly from the beginning of therapy, as an alternative choice to the present hospital-based intravenous dosing each two weeks.
The potential approval of the SC-AI formulation would increase therapy choices for care companions and sufferers, permitting Leqembi for use at residence.
Every 250mg autoinjector has an injection time of 15 seconds. The subcutaneous formulation may additionally cut back healthcare sources wanted for intravenous dosing, corresponding to nurse monitoring and preparation, streamlining the Alzheimer’s therapy care pathway.
Leqembi has acquired approval in 51 international locations and areas, with regulatory analysis ongoing in an extra 9. Eisai oversees international growth and regulatory actions and collaborates with Biogen on commercialisation and promotion efforts.
In November 2025, Eisai and Biogen introduced the UK MHRA’s approval for Leqembi for intravenous upkeep dosing as soon as each 4 weeks to deal with early Alzheimer’s.
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