Novartis' Lucentis gets its fourth approval in EU

Novartis' ($NVS) eye drug Lucentis has gained a new edge in its battle for market share with Regeneron's Eylea. Lucentis has been granted approval in Europe for a new indication, its fourth there.

The company said today that the EU has approved Lucentis for treatment of sight problems caused by choroidal neovascularization (CNV) secondary to pathologic myopia (myopic CNV). The condition often strikes people under the age of 50, and 9 out of 10 times it will lead to severe vision loss within 5 years if not treated. The company said today in a release that up to 3% of the population worldwide is affected by the condition. It also said that in trials, more than 70% of patients treated with one injection of Lucentis quickly experienced vision improvement.

"This fourth indication for our pioneering ophthalmology drug, Lucentis, shows how far we have come since it was first launched in 2006," Tim Wright, Novartis' global head of development, following the approval.

As Pharma Times points out, Lucentis was already approved in the E.U. for the treatment of wet age-related macular oedema, for diabetic macular edema and for visual impairment caused by macular edema secondary to central or branch retinal vein occlusion. Roche's ($RHHBY) Genentech sells the drug in the U.S.

Lucentis has been facing a significant challenge from Bayer Healthcare and Regeneron's ($REGN) hard-charging eye drug Eylea for treatment of wet age-related macular degeneration. The drug has been gaining market share from Lucentis since being approved in the U.S. and the EU. In late May, the U.K.'s National Institute for Health and Care Excellence (NICE) recommended Eylea for treatment of that condition after the company offered up an undisclosed discount for the drug.

- here's the release
- more from Pharma Times

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