FDA advisory committee recommends approval of Vanda Pharmaceuticals’ Hetlioz for non-24-hour disorder in the totally blind
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.
Number of drugs approved by FDA in 2013 fewer than 2012, but higher in value, study finds
NEW YORK — The value of drugs approved in the United States this year could reach almost $19 billion in sales five years after their launch, exceeding the value of drugs approved in 2012, according to a new report.
The report, by EP Vantage, part of EvaluatePharma, found that the total potential value of drugs that won Food and Drug Administration approval in 2013 was $18.7 billion in their fifth year. The total number of drugs approved or expected to be approved by the Food and Drug Administration this year, 34, is behind last year’s record 43, but their fifth-year sales are expected to be 14% higher.
Drugs like Biogen Idec’s multiple sclerosis treatment Tecfidera (dimethyl fumarate) and GlaxoSmithKline’s chronic obstructive pulmonary disease treatment Breo Ellipta (fluticasone furoate; vilanterol) are expected to play a significant role in the total. And if it wins FDA approval, Gilead Sciences’ hepatitis C drug sofosbuvir is also expected to contribute significantly to the total, with almost $3 billion in sales expected in the fifth year after launch, according to EP Vantage.
J&J, Pharmacyclics add Diplomat to limited distribution network for Imbruvica
FLINT, Mich. — Diplomat has joined the limited distribution network for a rare form of blood cancer drug marketed by Johnson & Johnson and Pharmacyclics.
The specialty pharmacy said Thursday that J&J subsidiary Janssen Biotech and Pharmacyclics had added it to the limited distribution network for Imbruvica (ibrutinib), which the Food and Drug Administration approved this week for mantle cell lymphoma.
"We are pleased to partner with Pharmacyclics and Janssen Biotech Inc. as a specialty pharmacy provider of Imbruvica," Diplomat president Gary Kadlec said. "Diplomat has proven expertise in handling limited distribution drugs and an industry-wide reputation for comprehensive patient care outreach that improves patient compliance, adherence and outcomes."