Merck receives approval for Alzheimer’s label claim for insomnia drug
Merck & Co/MSD has claimed FDA approval for a new use of its insomnia drug Belsomra, treating sleep disruption in people with mild-to-moderate Alzheimer’s disease.
Belsomra (suvorexant) has been approved since 2014 for treating insomnia in the general population characterised by difficulties with falling or staying asleep, becoming the first in a new class of drugs targeting orexin, a brain chemical involved in regulating sleep cycle.
Since then, it’s been joined on the market by Eisai’s recently approved Dayvigo (lemborexant), which is also being tested in Alzheimer’s-relate sleep disturbances and reported positive results in a phase 2 trial in 2018.
People with Alzheimer’s dementia typically experience poor sleep and disruption of circadian rhythms that lead to night-time activity and daytime sleepiness.
Sleep disturbance is estimated to affect up to 25% of people with mild-to-moderate dementia and 50% of people with severe dementia, with symptoms tending to get worse as dementia progresses in severity.
Critically, unlike some other insomnia drugs like zolpidem, Belsomra doesn’t seem to lead to a significant increase in confusion and falls in people who are cognitively impaired.
Belsomra is a relatively minor product for Merck, bringing in just $223m in the first nine months of 2019 amid an insomnia drug market that has become dominated by low-cost, generic drugs.
Nevertheless, it accounts for a sizeable chunk of the total insomnia market by value and is expected to help grow the category from $2.7bn in 2018 to $4.3bn in 2026, according to an Acute Market Research report.
Peak sales of Belsomra are expected to reach around $500m, with the Alzheimer’s indication expected to help the product achieve that increase.