VIVUS – Possible Negative Opinion on Qsiva in EU – A Hiccup

Date: 2015-07

Vivus (VVUS) announced that EMEA is likely to recommend against the approval for Qsiva (R-EU, a combination of phentermine and topiramate) in EU based on its preliminary discussion. Formal verdict is expected following CHMP’s October meeting and if it is negative, VVUS will either resubmit MAA or appeal the decision and will request a re-examination. This could result in a delay or in the worst case, no launch in EU. In this report, we have analyzed scenarios for VVUS and also discussed, ‘Why there will no significant switching at certified home delivery pharmacies?’ For more details, please read our report, released on 21st Sept., 2012 on VVUS titled, “VIVUS – Possible Negative Opinion on Qsiva in EU – A Hiccup”.

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