Few developers have enjoyed the kind of attention that's been lavished on the three biotech companies seeking approval for their new obesity drugs. The focus will hit fever pitch Thursday when an FDA advisory panel steps up to review Vivus' (NASDAQ: VVUS) Qnexa. All the developers--including Orexigen (NASDAQ: OREX) and Arena (NASDAQ: ARNA)--have a lot riding on the outcome.
As the Wall Street Journal explains, the agency plans to review each of the drugs as candidates for long-term use. That approach will significantly raise the bar on any safety issues, which have created marketing migraines for pharma companies in the past and created a decade-wide abyss on new approvals for weight therapies.
Vivus is seeking an approval of a drug that combines the anticonvulsant topiramate with phentermine, and the experts and staffers will want to explore both the "neurologic and psychiatric effects of topiramate and the cardiovascular impact of phentermine," says the WSJ.
The results of Thursday's meeting could play a big role in determining the outline of any new marketing pacts for the drugs. Only Arena has struck a pact so far, inking a U.S. deal with Eisai. That leaves plenty of wheeling and dealing yet to be completed. Roughly a third of the U.S. population is obese, making this a blockbuster market for any approved therapy that proves to be safe, HealthcareDigital notes.
"There's no obvious clear winner," Leerink Swann analyst Steve Yoo says, as quoted by HealthcareDigital. "If you look at different aspects, each drug shines." The FDA's staff review of Qnexa is expected later today.
- here's the story from the Wall Street Journal
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