FDA rejects Aeterna's growth hormone diagnostic test

Thu Nov 6, 2014 7:34am EST
 
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Nov 6 (Reuters) - Aeterna Zentaris Inc said the U.S. Food and Drug Administration rejected macimorelin, an experimental test designed to determine if adults' pituitary glands are secreting enough growth hormone.

The Canadian company's U.S.-listed shares slumped 50 percent to 65 cents in premarket trading on Thursday.

The company's trial did not meet its main goal, the FDA said, also noting the lack of "complete and verifiable" source data used to determine if adult patients were accurately diagnosed with growth hormone deficiency (AGHD).

"In light of the failed primary analysis and data deficiencies noted, the clinical trial does not by itself support the indication," the agency concluded.

The FDA asked Aeterna to conduct a new trial to demonstrate the effectiveness of macimorelin. (Reporting by Natalie Grover in Bangalore; Editing by Savio D'Souza)