FDA Rejects San Diego Made Weight Loss Drug
Monday, October 25, 2010
The FDA has rejected a new obesity drug made by San Diego-based Arena Pharmaceuticals. But the company is optimistic it can change the FDA’s mind.
Arena is not giving up on its weight loss drug lorcaserin, also known as Lorqess. Arena spent about a billion dollars and a nearly a dozen years in research and development.
In a written statement, Arena’s CEO Jack Leif said “We will work with the agency to address the issues with our new drug application as quickly as possible.”
The FDA said they rejected lorcaserin because it had “marginal” effectiveness and early studies in rats, showed high doses of the drug were linked to cancer.
Arena will have to prove the rat studies do not correlate to humans or they’ll need to do more costly clinical trials.
"We believe we have a path froward to obtain approval," Leif added.
The San Diego based company, along with it's Japan-based partner, Eisai Pharmaceuticals vowed to meet with FDA regulators to try and "resolve" the issues with the drugs application.