XOMA's Gevokizumab Approval As Orphan Drug For Pyoderma Gangrenosum

XOMA Corporation announced in a press release that the Food and Drug Administration (FDA) has approved gevokizumab as an orphan drug. The IL-1 beta-modulating antibody is indicated for the treatment of pyoderma gangrenosum (PG). The company also has a Proof-of-Concept (POC) program to explore gevokizumab for multiple diseases and conditions. John Varian, Chief Executive Officer of XOMA said, "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.”

Pyoderma gangrenosum (PG) is a rare disease. Patients develop skin ulcers, which are often serious and painful. About 1 in 100,000 people have the condition. Little more than half of cases can be attributed to an underlying condition but other cases often have no apparent cause. People may visit a physician but the condition may not be diagnosed right away, leading to a delay in treatment and worsening outcomes. Treatment with corticosteroids or ciclosporin is effective but better treatments are needed because about half of treated patients relapse.

Gevokizumab is an antibody with potential in inflammatory diseases. It binds to interleukin-1 beta (IL-1 beta) cytokine to influence the inflammatory response. XOMA is also studying the drug in a Phase III clinical trial for people with non-anterior non-infectious uveitis (NIU) and patients with Behçet's uveitis. The company’s Proof-of-Concept (POC) program reported positive results in treating severe acne. Ongoing studies include treatment with gevokizumab for active non-infectious anterior scleritis, erosive osteoarthritis of the hand, atherosclerotic plaque inflammation, polymyositis/dermatomyositis, giant cell arteritis, and Schnitzler syndrome.

About XOMA and Servier

XOMA is a pharmaceutical company that focuses on preclinical research and late-stage clinical development with an emphasis on antibody research and allosteric modulation. Gevokizumab is its leading product and is being developed in conjunction with Servier, a French pharmaceutical research company. Servier’s focus is on drug development for cancer, joint disease, cardiovascular disease, and metabolic conditions. The two companies have made development and financial agreements including the 2011 agreement to commercialize XOMA 052, an anti-inflammatory drug candidate and the 2013 agreement to start the Proof-of-Concept (POC) clinical program to study gevokizumab.