The company has requested a meeting with the FDA to determine whether existing data are sufficient to respond to the agency’s concerns or whether additional studies will be required. If more studies are needed the FDA request could constitute a significant delay in the drug’s path to market.
The agency expressed concern regarding hypercalcemia associated with the proposed daily dose of Preos and has requested additional clinical information. The agency also requested additional information regarding the reliability and use of the injection device for delivery of the drug.
The FDA indicated that the company’s pivotal study with Preos demonstrated significant fracture risk reductions in postmenopausal women with osteoporosis, but noted the higher incidence of hypercalcemia with Preos compared to placebo.