REFILE-Eisai Inc announces U.S. approval for insomnia drug

(Corrects third paragraph to say orexin, not oxerin)
By Trisha Roy
Dec 22 (Reuters) - Japan-based drugmaker Eisai Co's 4523.T
U.S. subsidiary announced on Sunday that it had received
approval from the U.S. Food and Drug Administration for its
insomnia treatment in adult patients.
The agency approved the drug, Dayvigo, in doses of 5 mg and
10 mg based on two late-stage studies testing the drug in
patients with insomnia versus placebo for up to one month and
six months, the drugmaker's U.S. subsidiary said.
The treatment belongs to a new class of medications, which
target the orexin system, joining the ranks with Merck & Co's
MRK.N Belsomra, which was approved in 2014.
Dayvigo acts on the neurotransmitter system in the brain to
suppress the wake drive, as opposed to existing prescription
insomnia medicines, which target the sleep centers of the brain
to increase the sleep drive, Eisai said.
FDA has recommended Dayvigo to be classified as a controlled
substance because it can be addictive and has the potential to
be abused. The recommendation has been submitted to the U.S.
Drug Enforcement Administration (DEA), the company said.
Following the DEA scheduling of Dayvigo, which usually takes
90 days, Eisai plans to launch the drug by early April of 2020.
The company has already made approval submissions for
Dayvigo in Japan and Canada and is currently testing the drug in
other sleep disorders including in Alzheimer's patients.
Patients on Dayvigo during the late-stage trials did not
show any meaningful effect on their postural stability and
memory and were balanced in their next-day activities as
compared to placebo, the company said.
However, Eisai pointed some caution is to be taken while on
the 10 mg dose as it may cause some difficulty in driving the
next day after the medication.
Insomnia is characterized by difficulty falling asleep or
staying asleep, which leads to fatigue, trouble concentrating,
and irritability. It affects about 30% of the adult population
worldwide, according to a survey conducted by the company.
Eisai said Dayvigo is an important addition to its rapidly
growing neurology portfolio and underscores the company's
leadership in neuroscience, making it the first FDA-approved
medication to report safety data over a 12-month period.
The drug should not be consumed by patients with narcolepsy.
Dayvigo may lead to complex sleep behaviors and can impair
daytime wakefulness.
The drugmaker plans to market the drug independently within
the United States as well as worldwide and has initiated talks
with potential health insurers.
Once the drug is launched, Eisai plans to provide copay
cards, which are savings programs offered by drugmakers that
help patients afford expensive prescription drugs by reducing
out-of-pocket costs.