FDA Rejects United Therapeutics’ Oral Pulmonary Arterial Hypertension Drug For Second Time

U.S. health regulators vetoed – for a second time – an oral hypertension drug manufactured by United Therapeutic Corp., a biotechnology company. The company’s shares dropped six percent on Nasdaq’s early trading after the news.

There was no news if the drugmaker plans on pursuing approval for its tablet.  However, Martine Rothblatt, chief executive for the company, said its confident oral treprostinil will help in the treatment of pulmonary arterial hypertension.

The U.S. Food and Drug Administration rejected the drug – treprostinildiolamine – the first time because it did not show any noteworthy outcomes in patients taking the six-minute walk test during its experimental trials.

According to Liana Moussatos, a Wedbush analyst, the company is likely to do another late-stage trial like it had planned originally. She said after the drug was rejected the first time, the company believed it would need to do a late-stage trial – for around four year s – before they could submit the application again for marketing approval.

Some additional research was done and some historical information was brought in for the second go-around. If tried again for a third time, the drug would not get FDA approval until 2017.

United Therapeutics currently has the following hypertension drugs on the market: a treprostinil injection dubbed Remodulin and Tyvaso, an orally inhaled version. Pulmonary arterial hypertension is a disease that’s described as having an unusually high blood pressure in the pulmonary artery that brings blood to the lungs from the heart.

According to Moussatos, the company is not in danger of failing because of the rejection of the oral treprostinil. Lead product Remodulin made around $458 million last year, which is half of the company’s net revenue. It also sells an oral tablet for treating PAH dubbed Adcirca.

Most people prefer the oral drug versions of other forms of medication administration.

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Posted by on Mar 25 2013. Filed under Business, Health. You can follow any responses to this entry through the RSS 2.0. Both comments and pings are currently closed.

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