The open label clinical trial met its primary objective of maintaining the bone mineral density (BMD) of women with systemic lupus erythematosus (SLE or lupus) receiving glucocorticoids. The study measured the effect of Prestara on BMD for a period of one year.
All 115 patients in the study received Prestara, either 100 or 200mg per day, with approximately two-thirds of the patients receiving 200mg per day. While the trial was not designed with a placebo control, it was randomized and all of the patients’ BMD scans were sent to a centralized reading site. All patients enrolled were taking glucocorticoids, which normally cause a decrease in bone mineral density.
Preliminary results demonstrated that patients who received 200mg of Prestara per day increased their BMD by approximately 0.9% during the 12 months. Results also demonstrated that patients who received a lower dose of Prestara, 100mg per day, did not increase their BMD during the clinical trial, and in fact lost a measurable amount of bone mineral density.
The company concedes that the FDA normally does not consider open label studies to be sufficient to support approval of a new drug and has therefore scheduled a meeting with the FDA to discuss the company’s options for the development of Prestara for lupus, including the results of this clinical trial.
“Our analyses of these study results are continuing, however we expect to be able to submit them to the FDA in advance of an upcoming meeting, which we hope will provide additional clarity on what may be needed going forward,” said James Smith, president and CEO of Genelabs.