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Friday, Sep 20
Vivus gives update on pursuit of centralized procedure for Qsymia EU approval
- Vivus (VVUS -1.2%) updates investors on its European strategy for Qsymia.
- The company says it has submitted a request to the EMA for scientific advice on using a "pre-specified interim analysis from [AQCLAIM] to support the resubmission of the marketing authorization application ... under the centralized procedure."
- Recall that earlier this year, First Manhattan called the centralized procedure "the only pathway that large pharma uses for EU approval of blockbuster drugs," and dubbed the decentralized procedure (which VVUS was at one time considering) "a path to nowhere."
- The company says it will begin AQCLAIM patient enrollment in Q1 2014 in order to "accommodate advice from the European authorities."
- CEO Seth Fischer: "Leveraging the AQCLAIM CVOT data is a prudent and scientifically sound approach." (PR)