Meeting highlights from Europe's CHMP November 16-19, 2009

Following its November 16-19 meetings, the European Medicines Agency (EMEA) says it has reviewed further data on the centrally authorized pandemic vaccines, Celvapan (from Baxter International), Focetria (from Novartis) and Pandemrix (from GlaxoSmithKline). The Agency has reaffirmed that they have a positive balance of benefits and risks in the context of the current H1N1 infuenza pandemic.

Positive opinions for new medicines adopted

The Committee adopted positive opinions, recommending the granting of a marketing authorization, for the following new medicines

* Elonva (corifollitropin alfa), from NV Organon, intended for controlled ovarian stimulation for the development of multiple follicles in women participating in an Assisted Reproductive Technology program. The review of Elonva began on December 24, 2008, with an active review time of 205 days; and
* Urorec and Silodyx (silodosin), from Recordati Ireland, intended for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). The review for Urorec began on November 19, 2008, with an active review time of 205 days. The review for Silodyx began on July 26, 2009, with an active review time of 85 days and was aligned with that of Urorec.

Negative opinion for two medicines adopted

The Committee also adopted two negative opinions, recommending that the following medicines should not be granted a marketing authorization:

* Nenad (lisuride), from Axxonis Pharma AG, intended for the treatment of the signs and symptoms of Restless Legs Syndrome; and
* Oncophage (vitespen), from Antigenics Therapeutics. Oncophage is an autologous immunotherapy product, intended for the adjuvant treatment of renal cell carcinoma. Autologous immunotherapy products are produced by isolating tumor cells from an individual and processing these tumor cells into a formulation, which is then administered to the individual from whom the tumor cells were isolated to trigger an immune response against the tumour cells.

Positive opinions for generic medicines

The Committee adopted positive opinions for a number of generic medicines
* Docetaxel TEVA (docetaxel), from Teva Pharma BV, a generic of Taxotere, which is authorized in the European Union for the treatment of breast cancer, non-small-cell lung cancer, prostate cancer, gastric adenocarcinoma and head and neck cancer;
* Telmisartan Teva (telmisartan), from Teva Pharma BV, a generic of Micardis, which is authorized in the EU for the treatment of essential hypertension in adults; and
* Temozolomide Teva (temozolomide), from Teva Pharma BV, and Temomedac (temozolomide), from Alfred E Tiefenbacher GmbH & Co, generics of Temodal, which is authorized in the EU for treatment of glioblastoma and malignant glioma.

Extensions of indication - positive opinion adopted

The Committee gave a positive opinion for an application for an extension of indication, adding a new treatment option for Thyrogen (thyrotrophin alfa), from Genzyme BV. It recommended to extend the indication of the use of Thyrogen for ablation of thyroid remnant tissue to patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer and who do not have evidence of distant metastatic thyroid cancer. Thyrogen is currently authorized for testing undertaken for the detection of thyroid remnants and well-differentiated thyroid cancer in post-thyroidectomy patients maintained on hormone suppression therapy.

Extension of indication - negative opinion adopted for Avastin

The Committee adopted a negative opinion for Avastin (bevacizumab), from Roche, recommending that the current indication should not be extended to include the use of the medicine alone or in combination with irinotecan in patients with glioblastoma (WHO Grade IV malignant glioma) after relapse.