PHARMACY

FDA grants special status to GW Pharmaceuticals’ drug for rare epileptic disorder

BY Alaric DeArment

LONDON — The Food and Drug Administration has given orphan drug designation to an experimental treatment for a rare form of epilepsy.

GW Pharmaceuticals said Friday that the FDA had granted the designation to Epidiolex for Dravet syndrome, a severe, drug-resistant form of epilepsy that begins in infancy. The drug is an oral liquid of a highly purified extract of cannabidiol, a non-psychoactive molecule derived from the cannabis plant.

The FDA grants orphan drug designation to experimental treatments for diseases that affect fewer than 200,000 people in the United States. The agency has given physicians permission to use the drug to treat 125 children with Dravet syndrome. The disease affects about 5,440 people in the United States and causes lifelong, ongoing seizures and intellectual disability.

 

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FDA approves one-week antifungal drug made by Valeant

BY Alaric DeArment

LAVAL, Quebec — The Food and Drug Administration has approved a new drug for fungal infections of the skin made by Valeant Pharmaceuticals International, the drug maker said Friday.

The company announced the FDA approval of Luzu (luliconazole) cream in the 1% strength for treatment of athlete’s foot, jock itch and ringworm in adults.

"We are pleased to receive FDA approval earlier than expected," Valeant chairman and CEO J. Michael Pearson said. "This is the first safe and effective product indicated for daily use over a one-week period. This will be a welcome alternative to current options that require two weeks of treatment, and we believe Luzu will position us well to address this growing, unmet need."

 

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FDA advisory committee recommends approval of Vanda Pharmaceuticals’ Hetlioz for non-24-hour disorder in the totally blind

BY Alaric DeArment

WASHINGTON — A Food and Drug Administration expert panel has voted to recommend approval for a drug to treat a circadian rhythm disorder that affects most people with total blindness.

Vanda Pharmaceuticals said the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee had voted overwhelmingly to recommend approval for Hetlioz (tasimelteon), a drug for non-24-hour disorder. Non-24-hour disorder, also called non-24, is a chronic disorder characterized by the inability to synchronize the body’s internal clock with a 24-hour day-night cycle, affecting between 65,000 and 95,000 totally blind people.

"We are extremely pleased that the FDA’s advisory committee has recommended that the FDA approve Hetlioz for the treatment of non-24 in the totally blind," Vanda president and CEO Mihael Polymeropoulos said. "We are now one step closer toward our goal of providing a treatment option that addresses the physiologic cause of this serious, debilitating orphan condition that impacts a majority of totally blind individuals."

The drug has priority review status from the FDA, which the agency grants to drugs that, if approved, would mark a significant improvement over existing treatments; there is currently no FDA-approved treatment for non-24. An advisory committee vote in favor of recommending approval does not guarantee the FDA will approve a drug, but the agency usually follows advisory committee votes.

 

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