Avastin less safe than Lucentis as AMD therapy
02.05.2012 - Results from a NIH study confirm that treating wet AMD with unlicensed Avastin (bevacizumab) leads to more adverse effects than Novartis’ Lucentis.
Basel - Novartis AG has highlighted results from a head-to-head study comparing safety and efficacy of the VEGF antibody fragment Lucentis (ranibizumab) with the full VEGF antibody Avastin (bevazizumab) in wet AMD therapy. According to the NIH-funded CATT study (Comparison of Age-related macular degeneration Treatment Trials), Lucentis showed superior safety when compared to Avastin, which has been not approved as treatment for wet AMD but has been broadly used off label by ophtalmologists due primarily to a 50fold lower price.
According to Novartis, which has licensed marketing rights from Roche for Lucentis, two year data from 1107 patients confirm 30% higher risk of serious systemic adverse events with unlicensed bevacizumab versus Lucentis. Additionally, the Swiss pharma major pointed to reports of arteriothrombotic events, systemic haemorrhage, congestive heart failure, venous thrombotic events, hypertension and vascular death, which were more frequent in bevacizumab treated patients. These events have been previously associated with systemic anti-VEGF treatment.
"The apparent differential safety risk between the two medicines may be due to differences in the molecules and their commercial formulation“, said Tim Wright, Global Head of Development, Novartis Pharma. Previously published retrospective Medicare analyses compared the safety of unlicensed ocular bevacizumab and Lucentis for treating wet AMD. The primary analysis from the Curtis study showed that unlicensed bevacizumab and Lucentis were not associated with increased risks of death, heart attack, bleeding or stroke compared with photodynamic therapy or pegaptanib. A secondary analysis in the Curtis et al study, which included approximately 40,000 patients, showed a significantly higher risk of mortality (16%) and stroke (28%) with unlicensed intravitreal bevacizumab than with Lucentis. Gower et al. assessed 77,886 Medicare beneficiaries with wet AMD over 10 months. In this study patients treated with unlicensed intravitreal bevacizumab experienced an 11% significantly increased risk of death and a 57% significantly increased risk of haemorrhagic stroke compared to patients treated with Lucentis. The risk of ocular inflammation was 80% higher with unlicensed intravitreal bevacizumab than with Lucentis.