3 Big Lessons Learned from FDA Approval of Obesity Drug Lorcaserin
Lorcaserin marks the first successful obesity drug approval in more than 12 years. Arena’s perseverance and challenges to gain approval of lorcaserin—to be marketed as Belviq—illustrates three important lessons for drug developers.
Lesson #1
Drug development is not a linear process.
The FDA asked the pharmaceutical company to go back and provide more data to determine if there was an increased risk of cancer associated with the compound. After proving the risks to negligible, lorcaserin was approved the second-time around.
Lesson #2
Cardiovascular effects are not necessarily a death-knell to approval.
Although the FDA cited concerns about possible adverse cardiovascular events associated with lorcaserin, the compound was still approved. This is especially enlightening as cardiovascular issues hit the heart of the obesity drug development debate and prompting the FDA to heighten cardiac safety requirements for obesity drugs.
Also, the FDA has asked the drug maker to continue to track data on six post marketing studies, including a long-term CV outcomes trial.
Lesson #3
From discovery through post-market approval, the FDA is consistently looking for cardiovascular due diligence.
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- Lorcaserin,
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