Eisai And Arena Pharmaceuticals Get FDA Approval For BELVIQ XR Extended-Release Tablets
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) and Eisai Inc. revealed that the Food and Drug Administration has approved its New Drug Application (NDA) for BELVIQ XR (lorcaserin HCl) CIV extended-release 20 mg tablets. According to the company, the new formulation of lorcaserin would provide patients a once-a-day dosing option that might help them achieve, as well as maintain weight loss.
Arena expects BELVIQ XR to be available in the fall season of the current year. The company indicated it would get a $10 million milestone payment in connection with the latest regulatory approval.
The company's president and CEO, Amit Munshi, said, "We are pleased that once-daily BELVIQ XR has been approved by the FDA and will provide patients another option for weight loss. The approval of this new formulation is another example of Arena's success in supporting our collaborators."
Similarly, Eisai EVP for Neurology Business Group, Andrew Satlin, commented, "We're excited to offer this once-a-day option of lorcaserin. This option may provide another choice for patients who are overweight or obese and find it difficult to lose weight through diet and exercise alone. The development of this new formulation further underscores Eisai's ongoing commitment to help address the health care needs of this underserved population."
The companies disclosed that bioequivalence, as well as bioavailability of once-daily BELVIQ XR 20 mg compared with twice-daily BELVIQ 10 mg was based on two first stage registrational clinical studies among healthy adult subjects. The company added that the most common treatment-emergent adverse events were similar to those seen in the final stage of the clinical studies of BELVIQ 10 mg twice-daily.
The stock traded 8.8 percent up on Tuesday.
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