Kepivance (palifermin) Receives Positive Regulatory Opinion for Approval in Europe
7/29/2005 Thousand Oaks, CA press release Business Wire (www.businesswire.com) Amgen today announced that the European Committee for Medicinal Products for Human Use (CHMP), which is the scientific advisory panel to the European Medicines Agency (EMEA), has issued a positive opinion to approve marketing authorization for Kepivance(TM) (palifermin) in the European Union (EU). The CHMP opinion recommends authorization of palifermin to decrease the incidence, duration and severity of oral mucositis (mouth sores) in patients with hematologic (blood) cancers undergoing myeloablative therapy associated with a high incidence of severe oral mucositis, and requiring autologus bone marrow transplant. "Before palifermin, the best we could hope for in managing oral mucositis was to control the patient's pain with narcotics and oral rinses," said Jean-Luc Harousseau, M.D., head of the department of clinical hematology in the University Hospital of Nantes and former palifermin investigator. "With the potential approval of palifermin, physicians may be able to help protect transplant patients with hematologic malignancies from severe oral mucositis and may decrease their pain and discomfort." In patients with oral mucositis, the cells lining the mouth and throat are damaged by the chemotherapy drugs and/or radiation used in cancer treatment. Oral mucositis can be extremely painful and can have a devastating impact on patients. In fact, oral mucositis has been rated as the most debilitating side effect by patients with blood cancers undergoing bone marrow transplantation. Patients suffering from these debilitating mouth sores may require longer hospitalization, high doses of narcotics, such as morphine, and intravenous feeding to [...]