Apteka Exhibition Russian Health Care Week UFI Approved Event
To main
For exhibitors
For visitors
Program
Contacts

XOMA Receives Orphan Drug Designation From U.S. FDA for Pyoderma Gangrenosum

25.02.2014

BERKELEY, Calif., Feb. 24, 2014 (GLOBE NEWSWIRE) — XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced today gevokizumab, the Company’s IL-1 beta modulating antibody, has been granted Orphan Drug Designation by the U. S. Food & Drug Administration (FDA) for the treatment of pyoderma gangrenosum (PG).

Orphan drug designation is granted by the FDA Office of Orphan Products Development (OOPD) to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U. S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity, as well as tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance and waiver of Prescription Drug User Fee Act (PDUFA) filing fees. The OOPD also works on rare disease issues with the medical and research communities, professional organizations, academia, governmental agencies, industry, and rare disease patient groups.

«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," stated John Varian, Chief Executive Officer of XOMA. «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.»

Source: firstwordpharma.com


Back to the list


Invite partners to the exhibition
Facebook Youtube RSS Feed





Contacts Flashback Site map
119002 Moscow, Arbat str., 35, of. 423
Тel: +7 (495) 925-65-61/62
Fax: +7 (499) 248-07-34