GENELABS RECEIVES CONFIRMATION OF ORPHAN-DRUG DESIGNATION
Genelabs has provided an update on the development of Prestara, its investigational drug for lupus.
The FDA has confirmed that Prestara's indication for "prevention of loss of bone mineral density in systemic lupus erythematosus patients on glucocorticoids" qualifies for orphan-drug exclusivity under the company's original orphan-drug designation.
To obtain further information about the effect of Prestara on the bone mineral density of lupus patients, Genelabs is currently conducting an open label 12 month extension of the GL02-01 BMD study, which is designated Study GL03-01. This study is expected to be completed in August.