XOMA Gains Orphan Drug Designation to Treat Pyoderma Gangrenosum

February 25, 2014

The FDA approved XOMA Corporation's IL-1 beta antibody gevokizumab for the treatment of pyoderma gangrenosum (PG) under an orphan drug designation. PG is a rare disorder of expanding, painful skin ulcers, which affects one in about 100,000 people.

"Selecting pyoderma gangrenosum as our next Phase 3 indication reflects our commitment to creating and capturing value from gevokizumab, particularly in indications where patients have few effective treatment options," said John Varian, Chief Executive Officer of XOMA.

The FDA grants orphan drug designation to those drugs that treat rare diseases, which inflict fewer than 200,000 patients in the US. Once a corporation becomes designated, they have seven years to market themselves with tax credits for clinical research costs, the ability to apply for grant funding and waive the Prescription Drug User Fee Act.

"We intend to present what we believe are compelling data from our pilot study in PG and to solicit feedback from the FDA about the requirements for a Phase 3 program in this rare disease," said Varian.

Information on gevokizumab clinical studies can be found at www.clinicaltrials.gov and www.clinicaltrialsregister.eu.

Facebook Comments


We’re glad to see you’re enjoying PracticalDermatology…
but how about a more personalized experience?

Register for free