Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 January 2011

Positive opinions for new medicines adopted

The Committee adopted positive opinions recommending the granting of marketing authorisations for the following new medicines:

• Gilenya (fingolimod), from Novartis Europharm Ltd, intended for the treatment of adult patients with relapsing remitting multiple sclerosis with high disease activity. The review for Gilenya began on 21 January 2010 with an active review time of 181 days.
• Halaven (eribulin), from Eisai Europe Ltd, intended for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease. The review for Halaven began on 26 May 2010 with an active review time of 180 days.
• Jevtana (cabazitaxel), from Sanofi-aventis, intended in combination with prednisone or prednisolone for the treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen. The review for Jevtana began on 26 May 2010 with an active review time of 208 days.
• Pravafenix (fenofibrate/pravastatin), from Laboratoires S.M.B. S.A., intended for the treatment of adult patients at high risk of coronary heart disease with mixed dyslipidaemia. The review for Pravafenix began on 18 November 2009 with an active review time of 210 days.
• Trobalt (retigabine) from Glaxo Group Ltd, intended as adjunctive treatment of partial onset seizures in adults with epilepsy. The review for Trobalt began on 18 November 2009 with an active review time of 210 days.

Negative opinion for Fampyra adopted

The Committee adopted a negative opinion recommending that Fampyra (fampridine), from Biogen Idec Ltd, should not be granted a marketing authorisation. Fampyra was intended to be used to improve the walking ability of adult patients with multiple sclerosis.

Re-examination procedure on Movectro concluded

The Committee confirmed its previous negative opinion and adopted a final negative opinion, recommending that Movectro (cladribine), from Serono Europe Ltd, should not be granted a marketing authorisation. Movectro was intended as disease-modifying therapy in relapsing remitting multiple sclerosis.

Positive opinion for informed consent application adopted

The Committee adopted a positive opinion recommending the granting of a marketing authorisation for Riprazo HCT (aliskiren/hydrochlorothiazide), from Novartis Europharm Ltd, intended for the treatment of adult patients with essential hypertension. The review for Riprazo HCT began on 21 November 2010 with an active review time of 60 days. This application was an informed consent application referring to the dossier of the authorised medicine Rasilez HCT.

Positive opinions for extensions of therapeutic indications adopted

The Committee adopted positive opinions for applications for extensions of the therapeutic indications, adding new treatment options for medicines that are already authorised in the European Union (EU), for:

• Baraclude (entecavir), from Bristol-Myers Squibb Pharma EEIG, to include treatment of adult patients with chronic hepatitis B virus infection and decompensated liver disease.
• INOmax (nitric oxide), from INO Therapeutics AB, to include treatment of pulmonary hypertension peri- and post heart surgery.
• Prezista (darunavir), from Janssen-Cilag International N.V., to include the treatment of HIV infection in adults who have been previously treated with antiretroviral therapy to the 400 mg strength.

New recommendations for use of Multaq

Further to the report of two cases of serious liver injury in patients taking the anti-arrhythmic Multaq (dronedarone), from Sanofi-aventis, the Committee recommended, as a precautionary measure, changes to the product information to help manage the possible risk of severe liver complications.

The Committee noted that although the two patients requiring a liver transplant were also taking other medications, a causal relationship with Multaq could not be excluded. Therefore, the CHMP decided that there was a need for urgent regulatory action to help manage the possible risk of severe liver complications with the medicine. The Committee recommended that warnings and precautions be introduced into the medicine's prescribing information, to ensure that patients' liver function is tested before initiation of treatment, closely monitored during treatment, and treatment is stopped if there are signs of potential liver damage.

The Committee also agreed that Sanofi-aventis should provide a letter to healthcare professionals explaining the changes in recommendations for use of Multaq.

Update on potential presence of endotoxins in Baxter peritoneal dialysis solutions

The Committee was informed by Baxter that the problem of endotoxins in peritoneal dialysis solutions has not been solved and that it cannot guarantee the production of endotoxin-free solutions from a production line at its Castlebar plant in Ireland in the short-term. As a consequence, the CHMP, at the request of the European Commission, has started a full review of the manufacture of Baxter's dialysis solutions at the affected plant. The Committee has also updated its recommendations to healthcare professionals and patients.

Review on calcitonin-containing medicines started

The Committee has begun looking at the increased risk of prostate cancer progression and other types of malignancies in patients taking calcitonin-containing medicines for the prevention of acute bone loss. This follows the review of two randomised, double-blind, placebo-controlled clinical trials, suggesting an increased frequency of malignancies.

The CHMP will now review all available data thoroughly, including published data, non-clinical and clinical data, post-marketing reports and pharmacoepidemiological studies, and will assess their impact on the balance of risks and benefits of these medicines.

Notes

• The review of peritoneal dialysis solutions is being conducted in the context of a formal review, initiated by the European Commission on 18 January 2011, under Article 31 of Directive 2001/83/EC, as amended. The peritoneal dialysis solutions include Dianeal, Extraneal and Nutrineal. The Committee will make recommendations on whether the marketing authorisations for peritoneal dialysis solutions should be maintained, changed, suspended or revoked.
• The review of calcitonin-containing medicines is being conducted in the context of a formal review, initiated by the United Kingdom on 19 January 2011, under Article 31 of Directive 2001/83/EC, as amended.
  Calcitonin is a hypocalcaemic agent, which is authorised for the prevention of acute bone loss due to sudden immobilisation, such as in patients with recent osteoporotic fractures, Paget's disease and hypercalcaemia (when associated with malignant disease) and the treatment of established post-menopausal osteoporosis in order to reduce the risk of vertebral fractures. It is currently available in the EU in injectable and intranasal formulations of salmon or human calcitonin produced either by recombinant DNA technology or chemical peptide synthesis.