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)
THESE RESPONDER GROUPS WERE ALL 2-3 TIMES THE PLACEBO RATE
(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.
Approval in EU still look promising for Lorq (Belviq is US name).... my opinion for these reasons and also per recent updates by Arena..... Do your own DD and make your own decisions.
Total drop out rates for Lorq were 43.7% however, only 2.1% dropped out due to lack of efficacy. In comparison; Q total drop out rates were somewhat lower at about 38%, but remember they had a 4 week titration period that can influence the drop out data.... they also used a higher starting BMI in the second test.
More importantly, Lorc only had 7.9% drop out rate due to adverse events (pooled B+B data) vs 5.6% placebo and there was only one indication (mild transient headache) that exceeded placebo by greater than 5% (FDA cutoff guideline). Q high dose had 19% drop outs due to adverse events and this was more than double the placebo rate and 6 side effects greater than 5% over placebo..
Time will tell as to how these drugs are used for treatment... but, it appears that Lorq is better suited to be a first line treatment that patients might try to see if they are among the 2/3 high responders that obtain significant benefit from Belviq (Lorc), not counting any T2 DM benefits.