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Number of drugs approved by FDA in 2013 fewer than 2012, but higher in value, study finds

Drugs approved in 2012 to be worth $16.4 billion five years after launch; 2013 drugs expected to hit $18.7 billion

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.

 

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