H3 Pharma plans to address efficacy and manufacturing issues cited in an FDA "approvable" letter for Sanvar IR (vapreotide) during the first quarter of 2005.

The somatostatin analog was deemed "approvable" at FDA Dec. 21 for the acute treatment of esophageal variceal bleeding (¹ [A#14041228007]).

The FDA letter requests additional supportive efficacy data on Sanvar IR and additional information related to manufacturing aspects of the product, H3 Pharma said Jan. 4.

The company expects that a recently completed Phase III study performed in Eastern Europe involving 280 patients will satisfy FDA's request. H3 Pharma has no additional Phase III studies planned.

"This study has just been completed and an analysis of the results will allow us to follow-up with the FDA within a short timeframe," H3 Pharma said.

Sanvar IR is designated as an orphan drug.

- Andrew Shelton

H3 Pharma Plans First Quarter Response To Sanvar IR "Approvable" Letter

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