US FDA staff in favour of Vanda’s sleep-disorder drug ahead of committee meeting

Vanda Pharmaceuticals’ experimental sleep-disorder drug is safe and effective enough to warrant approval, according to a report posted by agency staff at the US Food and Drug Administration (FDA).

The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee is due to meet on November 14th to discuss approval of Vanda’s tasimelteon.

Tasimelteon (melatonin agonist) is a circadian regulator in development for the treatment of Non-24 Hour Sleep-Wake Disorder (Non-24). Tasimelteon is a dual melatonin receptor agonist (DMRA) with selective agonist activity at the MT1 and MT2 receptors. Tasimelteon aims to reset the master body clock in the suprachiasmatic nucleus (SCN), resulting in the entrainment of the body’s melatonin and cortisol rhythms to align to the 24-hour day-night cycle.

Non-24 is a type of circadian rhythm sleep disorder that occurs in totally blind individuals due to loss of the normal input from the eyes about environmental light levels – in simple terms, when it is day versus night. The disorder can cause disrupted sleep patterns and excessive daytime sleepiness. It is a rare disease, affecting between 65000 to 95000 people.

Tasimelteon has been granted orphan drug designation for the treatment of Non-24 from both the US and the European Union. No drugs are currently FDA approved for Non-24.

The FDA is due to make a decision by January 31st 2014.

 

 

Related news:

FDA staff issue positive review of Vanda’s tasimelteon; shares jump (First Word Pharma)

U.S. FDA review supports Vanda sleep drug; shares surge (Reuters)

Reference links:

FDA advisory committee review notes

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