European Union - The Committee for Medicinal Products for Human Use (CHMP) gave positive opinions on initial marketing authorization applications for the following products.

• Aptivus® (tipranavir), from Boehringer Ingelheim International GmbH, for the treatment of human immunodeficiency virus (HIV-1) infection in highly pre-treated adult patients with virus that is resistant to multiple protease inhibitors.

• Kepivance® (palifermin), from Amgen Europe B.V., for the prevention and treatment of oral mucositis in patients with haematological (blood and blood-forming tissues) cancers undergoing myoablative therapy, which suppresses bone marrow activity.

• Noxafil® (posaconazole) and Posaconazole SP® (posaconazole), from SP Europe, for the treatment of certain invasive fungal infections in patients whose disease did not respond to certain commonly used antifungal agents or who were intolerant of these other agents.

• Procoralan®/Corlentor® (ivabradine), from Les Laboratoires Servier, for the treatment of chronic stable angina pectoris.

• Revatio® (sildenafil citrate), from Pfizer Limited, for the treatment of pulmonary arterial hypertension.

• ® Xolair (omalizumab), from Novartis Europharm Ltd., for the treatment of severe persistent allergic asthma.

Extension of indications and other recommendations

The Committee for Medicinal Products for Human Use (CHMP) adopted opinions for the extension of indications of products that are already authorized on the European Union.

• Keppra® (levetiracetam), UCB S.A., to extend the indication of adjunctive therapy in the treatment of partial onset seizures with or without secondary generalization to children from 4 years of age with epilepsy. Keppra was first authorized in the European Union on 29 September 2000.

• Remicade® (infliximab), Centocor B.V., to extend its indication to include treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systematic therapy including cyclosporine, methotrexate or PUVA.

• The Committee recommended a new contraindication for Forsteo® (teriparatide) to exclude patients with skeletal malignancies or bone metastases from treatment.

Summaries of opinion for initial marketing authorization applications, extensions of indication and other recommendations are available on http://www.emea.eu.int

Reference: EMEA Press Release, 28 July 2005. European Medicines Agency, Committee for Medicinal Products for Human Use, 25-28 July 2005 Doc. Ref: EMEA/246640/2005