This gives some insight into the process and perhaps Arena's decision to withdraw the MAA for Lorcaserin. It appears that Raxone received a negative opinion from CHMP and applied for reconsideration. From the withdrawal letter it seems that Santhera wanted to submit new data and analysis but was told that they couldn't so they withdrew the MAA. I'm thinking Arena withdrew before receiving a negative opinion to keep open the possibility of submitting new data. This info is included in the April CHMP monthly report. The reason for the negative opinion was that the benefit did not outweigh the risk.....something CHMP asked Arena to address.
If what some are saying is true, Arena will re-apply Locacsrien / Belviq as a diabetes drug first weight loss second making the benefits outweighing the risk, I did hear Robert say during the presentation that Arena is actively exploring other opportunities for Lorcaserin / Belviq.
OraNera: "Additional new data and analysis would be required in order to obtain a favorable opinion, which however the company is not able to generate within the timeframe allowed in the centralized procedure"
Ruvise: "This decision was taken since additional data are required in order to address CHMP questions relating to the benefit/risk assessment of imatinib in P AH patients. These data will not be available within the timeframe allowed in the Centralized Procedure."
Combimarv: "The decision to withdraw is in order to have sufficient time to repeat and submit bioequivalence T1D PK/PD data on each clamp study in order to comply with planned new insulin guideline, at a validated CRO.
Let's be honest here. There is perceived benefit and perceived risk. If CHMP stumbled the same way that shorts stumble on efficacy (seeing the 4% margin over placebo) then they are blind to the 11% weight loss among responders. That is a significant benefit in terms of real world experience.
Now, what exactly ARE the risks? Schedule IV classification means abuse potential is present but low. Heart valve damage was finally laid to rest this week with a published study. Rat tumors? I doubt it.
I like the idea that someone else floated here. Maybe Arena started to feel that the EU is just not clamoring for an obesity drug to start with. They turned Qsymia down and nobody else is in the wings presently (Contrave?). Perhaps Arena feels that the BLOOM and BLOSSOM trials were strong enough to re-submit as a Type II Diabetes drug. Nobody in their right mind could argue that diabetes is not a life threatening disease.