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UPDATE 2-Vivus jumps as FDA OKs obesity drug early resubmission
September 15, 2011 / 11:51 AM / 6 years ago

UPDATE 2-Vivus jumps as FDA OKs obesity drug early resubmission

* Says to resubmit Qnexa application in October

* Will not hold resubmission till Fortress study completion

* Shares up as much as 14 pct (Adds details, stock movement)

Sept 15 (Reuters) - Vivus Inc said the U.S. health regulator allowed it to make an early resubmission of a new drug application for its obesity drug Qnexa, sending the biopharmaceutical company’s shares up as much as 14 percent.

In October, the U.S. Food and Drug Administration denied approval for the drug and asked for evidence that higher heart rate associated with the drug does not increase the risk of major heart problems.

Thursday’s news would not only revive investors’ hopes in Qnexa, but also give a new lease of life to other obesity drug makers -- Arena Pharmaceuticals and Orexigen -- who faced FDA rejections last year.

While Vivus and Orexigen’s drugs were thought to have potential heart risks, Arena’s drug was rejected on possible cancer links.

The company, which had initially planned to resubmit the application after completion of its Fortress study, said it would now do so in October end.

The Fortress study analyzes the historical incidence of birth defects in offspring of women treated with the drug topiramate -- a component of Qnexa -- during the first trimester of pregnancy.

Results from the Fortress study are expected in December and validation expected in the third quarter of 2012, the company said.

However, results from another recent study showed that topiramate is not a major hindrance to the development of a fetus, the company said.

Topiramate has been used to treat seizures and migraines and is used in Qnexa in combination with phentermine.

The company said the FDA also permitted it to seek approval for an initial indication that includes obese men and women of non-child bearing potential, adding that FDA’s advisory committee meeting on the drug will be held in the first quarter of 2012.

Shares of Mountain View, California-based Vivus have fallen more than 20 percent since January when the FDA delayed Qnexa’s approval.

The stock was trading up 12 percent at $9.48 on Thursday, making it one of the top gainers on Nasdaq. Orexigen shares were up 5 percent, while Arena was trading up 4 percent. (Reporting by Zeba Siddiqui and Esha Dey in Bangalore; Editing by Roshni Menon)

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