Ranibizumab approved by Health Canada, gains priority review for sBLA from FDA

October 14, 2014

Health Canada has approved Novartis Pharmaceuticals Canada’s ranibizumab (Lucentis) for the treatment of visual impairment due to choroidal neovascularization secondary to pathologic myopia (mCNV).

Dorval, Canada and South San Francisco, CA-Health Canada has approved Novartis Pharmaceuticals Canada’s ranibizumab (Lucentis) for the treatment of visual impairment due to choroidal neovascularization secondary to pathologic myopia (mCNV).

According to the company, the treatment is an inhibitor of vascular endothelial growth factor. Treatment of vision loss from mCNV with the drug starts with a single injection, with further injections as needed based on disease activity, which is monitored monthly for the first 2 months, then at least quarterly for up to 1 year. After the first year, frequency of monitoring is at the discretion of the treating physician.

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The phase III study, on which the approval of the new indication was based, showed that treatment with the drug was superior to the previous standard of care, verteporfin PDT (Visudyne).

The treatment improved mean visual acuity by about 14 letters after 1 year. This result was achieved with a median of two injections over the 12 months. Over 60% of patients in the trial did not need any further injections after 6 months.

Previous treatments for mCNV aimed to stabilize vision but generally did not improve visual acuity.

Additionally, the FDA has accepted to file Genentech’s supplemental biologics license application (sBLA) and granted priority review of the drug for the treatment of diabetic retinopahy.

 

The FDA confirmed action date is Feb. 6.

“We are committed to the treatment of serious eye diseases for patients with diabetes and pleased the FDA is moving forward in its consideration of (the treatment) for diabetic retinopathy,” said Sandra Horning, MD, chief medical officer and head of global product development for Novartis.

The submission is based on results of the RISE and RIDE phase III trials in which meaningful improvements in the disease were observed in a clinically significant proportion of diabetic retinopathy patients treated with the drug at 2 years compared with patients treated with sham injections (control group). Benefits of the drug were maintained during year 3 of treatment.

The safety in the RISE and RIDE phase III trial was consistent with previous studies.

 

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