May 14 (Reuters) - Eisai ( ESALF ) and partner Biogen
said on Tuesday that the Japanese drugmaker has begun
submitting data on a rolling basis to the US health regulator
for a marketing application of a subcutaneous form of their
Alzheimer's disease drug Leqembi.
The companies are seeking the Food and Drug Administration's
(FDA) approval of a weekly dose of Leqembi to be given as an
under-the-skin injection.
Under a rolling submission the regulator assesses the data
as and when it becomes available, and the process continues
until there is enough data for a formal marketing application.
Eisai ( ESALF ) in April delayed filing for marketing approval of the
subcutaneous form of Leqembi, as the FDA had requested for
additional three-month immunogenicity data.
If approved, the injectable version of the drug could be
given to patients at home or at medical facilities as the
process requires less time than the intravenous formulation, the
companies said.
Under the weekly maintenance regimen, patients who have
completed the bi-weekly intravenous version would receive weekly
360 milligram doses of the drug as an under-the-skin injection.
The intravenous formulation of Leqembi, which received
standard approval last year has requirements such as additional
diagnostic tests, twice-monthly infusions and regular brain
scans which have contributed to a slower adoption of the drug
than markets were expecting.
Leqembi is an antibody designed to remove sticky deposits of
a protein called amyloid beta from the brains of Alzheimer's
patients.