US FDA "approvable letter" for NPS' Preos
The USA's NPS Pharmaceuticals says that the Food and Drug Administration has decided that the New Drug Application for its osteoporosis treatment Preos (parathyroid hormone [rDNA origin] for injection) is approvable.
However, the agency pointed out that the agent's pivotal study showed elevated levels of calcium compared to placebo and expressed its concern regarding hypercalcemia associated with the proposed daily dose. The FDA also requested more information on the reliability and use of the injection device for delivery of the drug.
NPS has requested a meeting to address these issues and to determine whether existing data are sufficient to respond to the agency's concerns. After these discussions, the firm says it will be better able to project the timing for approval and launch of Preos.
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