Novartis to file for new Lucentis indication
pharmafile | September 7, 2012 | News story | | Lucentis, Novartis, macular edema, macular oedema, ophthamology
Novartis is set to file eye treatment Lucentis for a new indication.
The firm will submit Lucentis (ranibizumab) to the EMA for a licence to treat choroidal neovascularisation (CNV), and also file with Japan’s regulator by the end of the year.
In new data from the REPAIR study Lucentis was shown to improve vision in patients with CNV secondary to pathological myopia (PM).
The results, presented at the 12th European Society of Retina Specialists Congress in Milan, showed that mean visual acuity in patients with myopic CNV improved by 12 letters after six months of treatment with Lucentis.
Patients received an average of three injections, with 29% requiring no further treatment after the first. At present, photodynamic therapy with Novartis’ own Visudyne (verteporfin) is the sole approved treatment.
Lucentis is already the only anti-VEGF therapy indicated to treat wet age-related macular degeneration (wet AMD), diabetic macular oedema (DME) and visual impairment due to macular oedema secondary to retinal vein occlusion (RVO).
These conditions can eventually lead to blindness if left untreated but it is estimated that over 80% of visual impairment from them is preventable – and all three licences allowed the drug to bring in revenues of more than $1 billion last year.
Yet while Lucentis has a strong position in the market, it is under pressure from the off-label use of Roche’s cancer drug Avastin (bevacizumab), which means that new indications – such as the one for CNV – would be welcome.
Last month, the day after gaining a US licence extension to treat DME, new data was published showing Avastin was just as effective at treating the disease.
The new study, published in the BMJ, concludes that there “is no difference in effectiveness” between them, although the authors admitted that a head-to-head study between the two drugs was needed to show if one were superior.
Novartis has already lowered the price of its drug in Switzerland and the UK.
Data from another study was also presented at the Milan conference, with the manufacturer highlighting the benefits of individualized treatment with Lucentis in an existing indication.
The RESTORE extension study found that DME patients originally treated with Lucentis received an average of 13.9 injections over three years.
Across all study arms, 19-25% of patients did not require any Lucentis injections during years two and three and an average of 3.7 injections in the second year and 2.7 in the third were sufficient to maintain the mean of seven letters of visual acuity gained in the RESTORE core study.
Tim Wright, global head of development for Novartis Pharma, said: “These new data confirm that an individualised treatment approach can lead to optimal improvements in vision with a low average number of treatments, thus ensuring that patients with retinal diseases are not over- or under-treated.”
Adam Hill
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