Decision delayed on United Therapeutics' Tyvaso

After scrambling to come up with new data on the experimental hypertension drug Tyvaso, United Therapeutics says it will now have to wait a few more months before it gets a decision from the FDA.

The agency shoved back the deadline for a decision from April 30 to July 30 so that it could review fresh data examining how well patients could follow the instructions on using the nebulizer needed for the inhaled therapy. Tyvaso is an inhaled version of the arterial hypertension drug Remodulin.

"We made every effort to conduct and submit the study as quickly as possible," said Roger Jeffs, United Therapeutics' president and chief operating officer. The company turned in the data earlier this month and warned of a possible FDA delay last month.

An injectable and intravenous version of Remodulin is available on the market. But investors punished the company severely by driving down the value of United Therapeutics' shares last fall after researchers revealed that an oral version of the drug had failed a clinical trial.

- read the report [1] from the Washington Business Journal

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United Therapeutics' stock plunges on trial failure [2]
United posts positive data for inhaled PAH drug [3]
United Therapeutics touts late-stage data for PAH drug [4] (2007)