Lucentis approved in Europe
pharmafile | January 26, 2007 | News story | Sales and Marketing |Â Â Lucentis, NovartisÂ
European regulators have approved Novartis’ Lucentis, a new treatment for neovascular age-related macular degeneration, known as wet AMD.
The company says Lucentis is the first drug to actually improve vision in patients, as opposed to only slowing or halting the decline in eyesight.
Dr James Shannon, global head of development at Novartis, said: “After nearly a decade of development, including rigorous clinical trials testing its safety and efficacy, Lucentis is the first treatment to show improvement in vision in a significant number of patients.”
He revealed that clinical trials were under way to evaluate the safety and efficacy of Lucentis in other eye diseases, such as diabetic macular oedema.
Analysts Lehman Brothers are predicting peak sales of $750 million for the drug, developed jointly by Novartis and US biotech giant, Genentech.
Novartis’ drug is designed to block the uncontrolled formation, growth and leakage of new blood vessels underneath the retina that lead to the development of the wet form of AMD and subsequent vision loss.
Lucentis now rivals Pfizer’s Macugen, which won EU approval in February 2006, making it the first anti-vascular endothelial growth factor (VEGF) treatment in ophthalmology to reach the market.
AMD is the leading cause of blindness of people aged 60 or over in the western world, affecting more than 26,000 people in Britain and between 25 to 30 million worldwide.
It is a degenerative eye disease affecting the macula – the central part of the retina at the back of the eye that is responsible for straight ahead central vision necessary for activities such as driving, telling the time, reading and identifying faces.
There are two types of AMD; dry and wet. Neovascular, or wet AMD accounts for about 15% of all AMD cases, but causes the majority of vision loss. It is associated with the growth of pathological new vessels under the macular that are fragile and leak fluid and blood. If not treated, scar tissue develops, destroying the macula.
Pivotal studies of Lucentis showed an unprecedented response rate among wet AMD patients. Approximately 95% of patients studied maintained their current level of vision and more than 68% gained some vision. To date, this vision gain has been sustained at two years with monthly Lucentis treatment.
The previous treatment for wet AMD was photodynamic therapy with Novartis’ Visudyne, but this is only suitable for around 7,000 patients in the UK each year.
MacDonald Curran, chairman of AMD Alliance International, said: “We now look forward to regulatory authorities in the EU member states continuing to recognise the value of Lucentis by reimbursing it as quickly as possible to avoid unnecessary blindness.”
In addition to the EU, Lucentis is already approved for use in patients with wet AMD in Switzerland, India and the US. Novartis expects approval decisions in Australia and Canada during the first half of 2007.
Controversy erupted last year after a report from the charity AMD Alliance UK found 90% of the 54 PCTs surveyed had not provided funding for Macugen because they were waiting for NICE guidance.
NICE appraisals of both Lucentis and Macugen are due in August 2007, the Institute deciding to delay Macugen’s appraisal until Lucentis was licensed.
Reports that Roche’s cancer drug Avastin, developed in partnership with Genentech, could be used to treat wet AMD and be cheaper that Macugen, also influenced PCTs to delay funding it.
Speaking out last November, Winifred Amoaku, consultant ophthalmologist at Nottingham Hospitals NHS Trust, said: “While we all appreciate the current funding situation, AMD is a major public health issue. With current figures estimating that blindness costs the UK a staggering £5 billion a year, we really need to do more to ensure patients have access to appropriate treatment sooner rather than later.”
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