WASHINGTON, Sept 11 (Reuters) - A clinical reviewer from the U.S. Food and Drug Administration on Tuesday recommended the agency approve Cornerstone Therapeutics Inc’s drug to treat low sodium levels in one condition.
Dr. Nancy Xu, a clinical reviewer at the FDA, said the drug lixivaptan should be approved to treat low sodium levels due to a condition that causes the body to have excess water. However, she said the drug should not be approved for heart failure patients, which the company had also sought.
The FDA staff review comes ahead of an advisory panel of outside experts, which will vote on whether to recommend the drug on Thursday. The FDA will make a final decision later, taking into account the panel’s recommendations.