Kiadis Pharma receives two orphan drug designations for Reviroc™ from the FDA
Biopharmaceutical company Kiadis Pharma announces today that the U.S. Food and Drug Administration (FDA) has granted its product Reviroc™ Orphan Drug Designations (ODD) for the treatment of two types of Non-Hodgkin Lymphoma (NHL). One ODD has been granted for diffuse large B-cell lymphoma and the other one for the treatment of follicular lymphoma. Reviroc™ is under development for the elimination of cancer cells from an autologous graft in bone marrow transplantations for end-stage blood cancer patients.
“This is an important strategic milestone in the development of Reviroc™ and we are very pleased with the orphan drug designations received from the FDA”, says Dr. Manja Bouman, Chief Executive Officer of Kiadis Pharma.
The FDA’s orphan drug designation is reserved for new therapies being developed to treat diseases or conditions that affect fewer than 200,000 people in the United States. The orphan drug designation provides for an accelerated review process, tax benefits, exemption from user fees and a seven-year period of market exclusivity in the US after product approval.
About Reviroc™
Reviroc™ is being developed as a treatment that eliminates blood cancer cells from autologous transplants for patients with end stage blood cancer. An autologous transplant uses the patient’s own bone marrow to serve as a graft. Bone marrow transplants are broadly recognized as a treatment option for patients suffering from blood cancers, such as leukemia and lymphoma. One of the limitations of autologous bone marrow transplantations is the high relapse rate associated with this treatment. This is often caused by the presence of cancer cells in the transplant. Reviroc™ has been developed to remove tumor cells from the graft.
More news
- Kiadis Pharma receives IND approval from FDA to start pivotal clinical trial with ATIR™ 8-7-2010
- Kiadis Pharma Provides ATIR™ Update: Two Year Follow-Up Data Show No Cases of Transplant Related Mortality - FDA grants ATIR™ Orphan Drug Status as a Medicinal Cell Based Therapy to Reduce Transplant Related Mortality 28-4-2010
- Kiadis Pharma announces enrollment of first patients in a multinational registration study for ATIR™ 29-11-2009
- Promising clinical data from Kiadis Pharma’s lead product ATIR™ will be presented at the 51st American Society of Hematology’s (ASH) Annual Meeting 5-11-2009
- Kiadis Pharma reports ATIR™ clinical data, further supporting its potential in mismatched bone marrow transplantations - ATIR™ data presented at the annual EBMT Presidential Symposium 8-4-2009
- Kiadis Pharma presents at the EBMT in Göteborg 31-3-2009
- Kiadis Pharma’s lead investigator presents results ATIR™ clinical trial at the BMT tandem meeting 6-2-2009
- Kiadis Pharma receives two orphan drug designations for Reviroc™ from the FDA 8-12-2008
- Kiadis Pharma announces positive clinical results for ATIR™ in mismatched bone marrow transplantations - Kiadis Pharma proceeds with pivotal trial ATIR™ 4-12-2008
- Kiadis Pharma announces continued collaboration with Professor Velardi on its lead product ATIR™ 28-11-2008
