Pharmaprojects R&D Pipeline News Feed
NICE - Lucentis gets the seal of approval
28 Aug 2008
The UK healthcare watchdog NICE has recommended Lucentis (ranibizumab), the age-related macular degeneration (AMD) therapeutic, for use in the National Health Service in a deal that also successfully caps the cost of treatment. AMD is the leading cause of vision loss in patients over 65 years with 85-90% of cases being 'dry' (non-neovascular) AMD; however, 90% of visual loss is a result of the 'wet' (neovascular) variety. Lucentis is designed to block abnormal blood vessel growth and the resulting leakage that occurs in wet AMD. It is a fragment of a recombinant anti-VEGF humanized antibody that was discovered by Genentech and is exclusively licensed to Novartis outside N America.
Lucentis is part of a recent ophthalmological revolution, alongside bevacizumab (Avastin), a similar anti-VEGF MAb, and pegaptanib (Macugen), an earlier anti-VEGF treatment developed by Pfizer. Prior to these drugs, patients with neovascular membranes were offered laser treatment or photodynamic therapy (PDT) with verteporfin dye injection and laser treatment, or were left untreated, usually suffering severe and permanent visual loss. PDT still leads to a loss of vision over the course of treatment.
Monthly Lucentis injections achieved significantly better outcomes than PDT in trials. Treatment for 1 year produced an average improvement in visual acuity of 8.5-11 letters, compared with a decline of 9.5 letters on PDT. Up to 40% of patients had a significant improvement of at least 15 letters on the eye chart, and 95% stabilised with no further loss of eyesight. Macugen also demonstrated superiority to PDT; however, it was associated with a vision loss over the course of treatment and was thus rejected by NICE as not being cost-effective.
Some analysts place Lucentis as a potential US$1 billion-a-year blockbuster, although not all agree as this depends on potential competition from Avastin. Britain may only account for less than 4% global pharmaceutical sales, but the decisions made by NICE can impact those made by other countries, and therefore non-US sales. In the US, Lucentis generated sales of US$223 million in 2007, dominating the AMD market. If Lucentis can demonstrate similar sales in non-US markets, it may reach the golden blockbuster target after all.
