Novartis seeks EU approvals for Exforge and Lucentis

Novartis (Basel, Switzerland) has submitted Exforge, its two-in-one tablet for the treatment of high blood pressure, for European approval.

The drug combines amlodipine, a calcium channel blocker, and valsartan, an angiotensin receptor blocker, and is aimed at patients who have to take multiple blood-pressure treatments.

'About two-thirds of patients currently take two or more drugs to control their blood pressure,' said James Shannon, head of development at Novartis. 'This can be very problematic since the burden of having to take multiple pills is one of the main contributors to poor compliance.'

Novartis is seeking approval for use in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy, and as replacement therapy for patients taking amlodipine and valsartan as separate tablets. A range of doses are planned.

In clinical trials of more than 5,000 patients Exforge was shown to reduce systolic and diastolic blood pressure and to cause a lower incidence of peripheral edema (fluid retention) in comparison to amlodipine as a monotherapy. It also exhibited 'excellent safety and tolerability'.

High blood pressure affects at least 25% of all adults and one billion people globally. Exforge is expected to be submitted for US approval in 2006.

The Swiss company has also submitted Lucentis (ranibizumab) for European approval for the treatment of neovascular age-related macular degeneration ('wet AMD') - the leading cause of blindness in over-60s in the western world, affecting over 25 million people.

AMD is caused by the growth of and leakage from abnormal blood vessels, known as choroidal neovascularization (CNV) or ocular angiogenesis respectively, under the macula, the part of the retina that is responsible for central vision.

Lucentis works by inhibiting this growth and leakage. A humanised monoclonal antibody fragment, it binds and inhibits VEGF-A, a protein that is believed to play a critical role in angiogenesis

The submission follows positive one-year clinical data on efficacy and safety from two pivotal Phase III trials (MARINA and ANCHOR), both of which showed Lucentis to maintain or improve vision in up to 96% of patients treated, regardless of baseline lesion type, lesion size or baseline visual acuity of the patient.

Two-year efficacy and safety data from the MARINA study showed continued Lucentis treatment to sustain beneficial vision effects achieved during the first year of treatment, while the vision of patients in the control group declined over the same period.

Under development by Genentech and the Novartis Ophthalmics Business Unit, Lucentis' commercial rights are owned by Genentech in the US and Canada, but by Novartis in the rest of the world. Novartis is thus looking to gain Lucentis approval worldwide and submitted it for approval in Switzerland in February.