Arena receives Day 180 List of Outstanding Issues from CHMP

theflyonthewall.com

Arena Pharmaceuticals disclosed earlier that it received the Day 180 List of Outstanding Issues from the EMA's Committee for Medicinal Products for Human Use, or CHMP. The issues will need to be addressed before the CHMP can recommend BELVIQ for marketing approval in the EU, the company said. The major objections relate to previously identified non-clinical and clinical issues, including tumors in rats, valvulopathy and psychiatric events, and the CHMP requests that the company further justify BELVIQ’s overall benefit-risk balance taking these issues into consideration. Arena has been asked to address the issues in writing. The CHMP also plans to consult with independent experts who will provide recommendations on the outstanding issues. The CHMP is expected to reach its final opinion on the BELVIQ MAA by Day 210, which Arena continues to expect in the first half of 2013.

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