By Mariam Sunny
Aug 29 (Reuters) - The U.S. Food and Drug Administration
has approved an injectable version of Eisai ( ESALF ) and
Biogen's Alzheimer's disease drug Leqembi, the
companies said on Friday, allowing for an easier treatment
option following an initial intravenous infusion.
The approval makes Leqembi the first Alzheimer's treatment
that can be administered at home as a weekly under-the-skin
injection, reducing the hassle for patients who now need to
travel to an infusion center twice a month for the process that
takes about an hour.
The potential for at-home administration could also increase
the treatment's availability for other patients, Lynn Kramer,
chief clinical officer at Eisai ( ESALF ), told Reuters ahead of the
decision.
"It actually may open up more infusion chairs for even
greater initiation of the therapy for patients," Kramer said.
The injectable version, branded as Leqembi IQLIK, was
approved as a maintenance dose for patients who have completed
18 months of bi-weekly intravenous (IV) infusions, the companies
said.
Patients would also have the option to continue IV infusions
once every month as maintenance instead of the weekly
subcutaneous injection.
The companies said Leqembi IQLIK would be launched to
patients by October 6 at an annual list price of $19,500 for the
360 mg single-dose prefilled autoinjectors.
Biogen has been counting on the expanded approval to
strengthen the adoption of Leqembi, which is gaining momentum
after a slow start in the U.S.
The treatment struggled as the small cognitive benefit could
not convince prescribing doctors to overlook the hefty price
tag, twice-monthly infusions and regular brain scans to guard
against potentially lethal side effects.
Leqembi and rival Eli Lilly's ( LLY ) Kisunla are designed
to clear sticky deposits of a protein called amyloid beta, a
hallmark of Alzheimer's disease.