) --The U.S. Food and Drug Administration has published the official minutes summarizing the discussion and outcomes of two advisory panels that reviewed the respective weight-loss drugs from
Both panels voted to recommend approval but tell me which sounds more positive:
Here is how the 20-2 vote in favor of Vivus' Qnexa is summarized in the
"The committee members who voted 'YES' in question #5 noted that obesity is a disease for which there are inadequate treatment methods and thatphentermine/topiramate (Qnexa) was shown to be effective in treating obesity with minimal adverse effects. However, they supported the requirement for a post-approval long-term cardiovascular (CV) safety trial which should be conducted expeditiously. It was noted that the sponsor should be held accountable for conducting and completing this CV trial. Additionally, these committee members agreed that the phentermine/topiramate REMS should capture additional data on long-term adverse events such as heart rate, psychological, cognitive functions, and birth defects. Several members highlighted the need to require treating physicians to be certified prior to treating patients with this agent and that the same requirement should be instituted for dispensing pharmacies. Lastly, the FDA was also urged to require the sponsor to continue to re-analyze any available data regarding reproductive outcomes such as birth defects."
And here's how the Arena panel's lorcaserin vote -- 18-4 (with one abstention) recommending approval -- is
"Many panel members indicated that it was a very difficult vote and they reluctantly voted 'Yes' that the benefits outweigh the risk for treatment of obesity patients since the magnitude of weight loss was moderate. Several panel members indicated that valvulopathy should be included in the Risk Evaluation and Mitigation Strategies (REMS) requirements and as part of the warning in the labeling and major adverse cardiovascular events (MACE) should be addressed as part of the phase 4 postmarketing cardiovascular trials requirements. Additional studies should be conducted to explore the issue of prolactin, tumor development, psychiatric effects and possible drug/drug interaction since this drug will probably be used in combination with other drugs. Echocardiogram should be required at the initiation of therapy and possibly at yearly physical check up."
Vivus' vote summary reads more positive than Arena's vote summary. No doubt about that, right?
Neither Qnexa nor lorcaserin comes across as pristine or perfect in their respective panel minutes. Qnexa's approval is expected to include significant warnings and a risk-management plan to deal with the potential risk of birth defects. The panel minutes reflect this:
"There was a general consensus from the committee that the data indicate an increase in the risk for oral clefs. However, it was difficult for the committee to discern whether the level of risk from the proposed dose of Qnexa (phentermine/topiramate) for obesity treatment would be comparable to that observed in the use of topiramate as asingle-agent for other indications at higher doses. The committee noted that obesity in and of itself poses risks to the fetus. The committee suggested that additional methods fordetecting birth defects may need to be implemented to further study the risk of oral clefs and other birth defects."
Vivus will be required to conduct a post-approval Qnexa heart-safety study because,
"The committee agreed that there is not enough data at this time to adequately assess the cardiovascular (CV) risk for phentermine/topiramate," according to the minutes.
Arena's lorcaserin is also under a similar heart-safety cloud:
"The committee agreed that there is not sufficient data at thistime to rule out a meaningful increase of risk of valvular heart disease. There is aconcern that the upper bound to rule out an increase is around 1.5 and some of theanalyses indicated that it’s higher than 1.5 and we would need further data to access thisissue. The committee noted the need to conduct large studies to rule out valvular heartdisease and assessment of other cardiac functions, such as cardiac remodeling, as part ofthe post-marketing requirement. There is a concern that in the real world whenlorcaserin is taken in combination with other agents and the possibility of drug-druginteractions arises that this could lead to an increase in the risk of valvular heart disease.Therefore, the potential for drug-drug interactions; should be studied further. Severalpanel members indicated that an echocardiogram has do be done at the initiation oftherapy and possibly during yearly physical check while the patient is on therapy. Somepanel members were concerned that patients who lose the most weight will probably betaking the agent the longest and will be exposed to the agent longer leading to a possibleincrease in risk for valvular heart disease, which will need to be studied further."
"There was ageneral consensus from the committee that a cardiovascular outcome trial should beconducted but as part of the post approval requirements.
We only have to wait two more days until FDA issues its approval decision on Arena's lorcaserin. Vivus's turn with Qnexa comes on July 17.
--Written by Adam Feuerstein in Boston.
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