Lucentis and Avastin Off-Label Use Information Center
On 2 December 2014, Italy’s Regional Administrative Tribunal of Lazio (TAR) upheld the earlier decision taken by the Italian Competition Authority (ICA) alleging anti-competitive practices between Novartis and Roche in Italy involving Lucentis® (ranibizumab, Novartis) and Avastin® (bevacizumab, Roche).
Novartis firmly rejects the accusations of anti-competitive practices and any allegations of anti-competitive behavior are unfounded and without merit. We will take all necessary steps to appeal this decision to the appropriate Italian court.
Novartis operates according to the highest standards and has always complied with Italian law and within the current Italian and European regulatory framework.
Novartis believes that the ICA and TAR decisions are in conflict with the European regulatory framework, which is critical to ensuring patient safety. All patients deserve access to medicines, which are prescribed and used according to approved indications.
October 16, 2014 14:00 CET
Novartis is aware that the topline results of the Diabetic Retinopathy Clinical Research Network (DRCR.net) Protocol T, a head-to-head open label study conducted in the US comparing Lucentis 0.3 mg (ranibizumab), Eylea 2 mg (aflibercept) and unlicensed intravitreal Avastin 1.25 mg (bevacizumab) for the treatment of visual impairment due to diabetic macular edema, (DME) were shared.
As demonstrated through studies involving more than 1300 patients included in 4 pivotal trials RESTORE, RESOLVE, RIDE and RISE, plus one DRCR.net study, Lucentis is an efficacious treatment for DME patients, providing rapid, significant and sustained vision gains for more than 3 years with decreasing injection frequency.
Lucentis has a well-characterized safety profile, with more than 2.8 million patient-treatment years of exposure globally. The well-established safety profile is supported by extensive clinical trial data and real-world experience.
Lucentis, licensed since 2011 for DME, is approved in more than 100 countries for DME. Lucentis has demonstrated transformational efficacy in the treatment of visual impairment in patients with DME, wet age-related macular degeneration (wet AMD), branch retinal vein occlusion (BRVO), central RVO (CRVO) and myopic choroidal neovascularization (myopic CNV).
Novartis awaits publication of the full results and further analysis of the data.