Novartis’ Lucentis recommended for wider EU licence
pharmafile | October 25, 2010 | News story | Sales and Marketing | CHMP, Genentech, Lucentis, Novartis, diabetic macular edema, ranibizumab
Novartis’ Lucentis has been recommended for approval in Europe to treat people suffering from vison loss due to diabetes.
The Committee for Medicinal Products for Human Use (CHMP) has given Lucentis (ranibizumab) a positive opinion for use in diabetic macular edema, a serious complication of the disease.
While it affects only a tiny percentage of diabetes sufferers, the disease is a leading cause of blindness in older people in many developed countries.
“Lucentis was designed specifically for use in the eye, and its efficacy and safety have now been demonstrated in patients suffering loss of vision due to DME through a robust programme of clinical trials,” said David Epstein, division head of Novartis Pharmaceuticals.
Two Novartis-funded clinical trials demonstrated Lucentis was better than dummy therapy or the current standard of care – laser treatment.
In the RESTORE trial patients were given Lucentis, Lucentis plus laser therapy or just laser therapy and then their performance on a standard ETDRS visual chart measured.
Those given Lucentis gained an average of 5.9 letters, and those treated with Lucentis and laser therapy gained an average of 5.5 letters, as compared to laser-treated patients.
The RESOLVE study showed Lucentis-treated patients achieved an average 11.7 letters gain in visual acuity at 12 months, compared to patients who received either dummy treatment or laser treatment.
Diabetic macular edema (DME) involves leakage from abnormal blood vessels in the macula of the retina, the part of the eye is responsible for sharp central vision.
Lucentis is injected into the eye and acts by neutralising the vascular endothelial growth factor protein which increases vascular permeability, resulting in capillary leakage.
The treatment was developed by Novartis with Genentech, and the latter has the rights to Lucentis in the US.
Lucentis is also approved there for the treatment of macular edema following retinal vein occlusion (RVO) and Novartis also plans to file in the EU for this indication.
Meanwhile, Genentech is conducting two phase III studies in DME patients, with results expected next year.
Lucentis is already approved for the treatment of wet age-related macular degeneration (AMD) in 85 countries.
Adam Hill
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