UPDATE 2-United Therapeutics lung drug faces delay, shares drop

lunedì 16 marzo 2009 18:12
 

* Says FDA raised questions regarding human factors testing

* Sees action on drug delayed beyond April 30

* Shares fall about 11 pct (Adds analysts' comments; updates stock movement)

By Esha Dey

BANGALORE, March 16 (Reuters) - United Therapeutics Corp (UTHR.O: Quotazione) said the approval for its inhaled drug to treat pulmonary hypertension could be delayed as it would have to conduct an additional study after the U.S. health regulators raised certain questions.

The U.S. Food and Drug Administration had questions regarding human factors testing and the instructions for use of the portable nebulizer that delivers the drug.

Analysts, however, do not see the additional study as a major roadblock and expect the approval of the drug, Tyvaso, to be pushed back by about six months.

"Instructions-for-use studies are among the most minor in terms of severity for device amendments," Leerink Swann analyst Joseph Schwartz said. He now expects the drug to be launched between mid-2009 and the first quarter of 2010.

United Therapeutics said it agreed to conduct human factors testing to validate that the revised instructions for use, which it had provided the FDA, results in the proper use of the device by a naive user.   Continua...