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Arena Pharmaceuticals, Inc. Message Board

  • diogenes_320bc diogenes_320bc Sep 21, 2012 10:18 AM Flag

    Prediction: Lorc will be approved in EU

    Lorcasersin will very likely be approved in the EU (and Switzerland)... The chances are very strong because (a) the EU emphasizes innovative new drug development, (b) they consider the complete efficacy profile with greater emphasis on treating related health problems like T2 Diabetes, (c) they are not bogged down by ITT-LOCF which can be influenced by titration and ignores drop outs due to adverse events, and finally (d) because the EMA recently approved Dapagliflozin (an SGLT2 diabetes drug) after it was rejected by the FDA.

    Lorc produces glycemic benefits that are in a similar range as dapa (and other T2DM meds including the blockbuster GLP-1 drugs like exenatide and liraglutide) with a far better safety profile and does not require injection.... not to mention the dosing tests indicate Lorc doses for T2DM could be cut in half, thus doubling all relevant safety factors.

    Completers that took Lorcaserin for a year had an average of 8% BW loss.
    63.9% lost AT LEAST 5% BW.
    34.7% lost AT LEAST 10% BW
    25% of patient lost an average of 35lbs (over 15%BW)
    (Source: the NDA briefing documents for Lorcaserin)

    Completers on Q lost roughly 10% BW mid-dose to 14% BW high dose....However, the Q glycemic improvement (for T2 Diabetics) is MUCH LOWER that for Lorc because it relies on weight loss alone.

    The EMA also has strong scientific capabilities and oversight mechanisms.

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