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Kepivance(TM) (palifermin) Receives Positive Regulatory Opinion for Approval in Europe
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--July 28, 2005--Amgen (Nasdaq:AMGN) 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 autologous 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 receive nutrition and maintain hydration. In the EU, approximately 13,000 cancer patients undergo autologous bone marrow transplant each year.
"Palifermin is an innovative medicine that helps meet a significant medical need for these cancer patients," said Willard Dere, M.D., senior vice president of global development and chief medical officer at Amgen. "Oral mucositis can be extremely painful for these patients and can impact their everyday lives. Once approved, palifermin will be the first and only therapy available in the EU that will enable physicians to focus on helping to protect these patients from oral mucositis by decreasing its incidence, duration and severity."
Recommendations from the CHMP are typically endorsed by the European Commission for marketing authorization within three to four months.
Kepivance was approved by the U.S. Food and Drug Administration (FDA) in December 2004. In the U.S., Kepivance is indicated to decrease the incidence and duration of severe oral mucositis in patients with hematologic cancers undergoing high-dose chemotherapy, with or without radiation, followed by a bone marrow transplant. The safety and efficacy of Kepivance have not been established in patients with non-hematologic malignancies. Amgen has also applied for regulatory approval in Australia, Canada and Switzerland.
Kepivance, a recombinant human keratinocyte growth factor, reduces the incidence and duration of severe oral mucositis by helping to protect existing epithelial cells that line the mouth and throat from the damage caused by chemotherapy and radiation, and stimulating the growth and development of new epithelial cells to build up the mucosal barrier. By reducing the incidence and duration of severe mouth sores, Kepivance helps patients continue normal daily activities, like eating, drinking, swallowing and talking.
In patients with hematologic malignancies, the most common serious adverse reaction in clinical trials attributed to Kepivance was skin rash reported in less than one percent of patients. Other serious adverse reactions occurred at a similar rate in patients who received Kepivance or placebo with the most frequent being fever, gastrointestinal events, and respiratory events. The most commonly reported adverse reactions attributed to Kepivance were rash, erythema, edema, pruritus, dysesthesia, mouth/tongue thickness/discoloration, and taste alteration.
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