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news.The US Food and Drug Administration (FDA) has refused Santarus and Pharming Group to file letter for the biologics license application (BLA) of Rhucin (recombinant human C1 inhibitor), which was earlier submitted by Pharming.
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The FDA said Rhucin BLA was not sufficiently complete to enable a critical medical review.
Additionally, it also said that thedata provided to the FDA from the previous studies in support of Rhucin BLA was not sufficient enough and also lacked prospective validation of the visual analog scale used in measuring the clinical effects of Rhucin.
FDA will give additional feedback regarding the design of the ongoing Phase IIIb clinical study, which had been initiated based on previous discussions with the FDA.
In addition, the FDA requested that the results of the Phase IIIb clinical study be included in any future BLA submission for Rhucin.
Santarus and Pharming are planning to meet the FDA discussing issues raised in the letter and to reach a more comprehensive understanding of what would be required for the BLA to be accepted for review.