FDA Grants Priority Review to Lucentis for wet AMD

On February 28th, the FDA granted Priority Review to Lucentis™ (ranibizumab) for the treatment of wet AMD (see the February 28, 2006, Genentech News Release). That means that the FDA must take action by the end of this June on Genentech’s application for approval. The patients in the MARINA trial, which compared Lucentis™ to sham treatment in patients with wet AMD, have now been followed for two years. The two-year results show that 90% of patients treated with Lucentis™ lost fewer than 15 letters of visual acuity compared to only 53% in the sham treatment group. These latest results confirm that the positive one-year results of Lucentis™ were maintained over a two year follow-up.

The ANCHOR study compared treatment with two different doses (0.3mg and 0.5mg) of Lucentis™ to treatment with Visudyne (PDT). The patients treated with Lucentis™ saw on average 20 letters (4 lines on chart) better than the patients treated with PDT.

Lucentis™ is clearly the best treatment available for wet AMD. Because Lucentis™ is not yet FDA approved, most retinal experts are using Avastin™ to treat either new patients or patients who are non-responsive to Visudyne™ (PDT) or Macugen™. Avastin™ is the parent molecule of Lucentis™ and appears to have the same positive effect. (see also blogs: 7/19/2005; 9/9/2005; 10/7/2005; 10/25/2005; 12/6/2005; 12/19/2005; 1/20/2006; 2/8/2006; 2/16/2006; 2/27/2006.)

The only thing that tempers the enthusiasm for Lucentis™ is that the cumulative rate of stroke and heart attack was 3% in the sham group, 4.6% in the group receiving 0.3mg of Lucentis™, and 4.2% in the group receiving 0.5 mg of Lucentis™.

At one year, the ANCHOR study showed no difference in the number of stokes (less than 1%) among the PDT and Lucentis™ groups. The only difference was that there was a slightly higher risk of heart attack (2.1% compared to 0.7%) in patients treated with the higher (0.5mg) dose of Lucentis™. All of these differences are minimal and not significant, but we need to watch for the corresponding rates from other studies.

If Lucentis™ is approved, how much will Genentech charge for it? The ophthalmological community hopes that it will have a reasonable charge unlike the very expensive verteporfin used in Visudyne™ treatment (PDT) and the equally expensive Macugen™. If the price is too high, ophthalmologists will be tempted to use Avastin™ instead, even though it is not approved for use in AMD.