The US Food & Drug Administration (:FDA) recently approved Roche Holdings Ltd.’s (RHHBY) Lucentis (ranibizumab injection) for the treatment of diabetic macular edema (:DME).
Lucentis is the first and only medicine to be approved by the FDA for the treatment of DME in more than 25 years. Before Lucentis’ FDA-approval, the standard of care for DME in the US has been laser surgery.
We note that this is the third indication for Lucentis in the US. First, the FDA approved the drug for the treatment of wet age-related macular degeneration (AMD) in 2006. Then, in 2010, Lucentis got FDA approval for macular edema following retinal vein occlusion (:RVO). Roche expects to begin shipment for the latest indication of the drug by August 15 this year.
Lucentis is marketed in the US by Genentech, a member of the Roche Group and outside the US by Novartis AG (NVS).
We remind investors that Lucentis’ FDA-approval for DME was based on Genentech’s phase III trials, RIDE and RISE.
Apart from Lucentis’ FDA-approval, Roche recently announced that a phase III study of Avastin along with radiation and temozolomide chemotherapy in patients newly diagnosed with glioblastoma met its co-primary endpoint. The study showed a significant improvement in progression-free survival (PFS) in patients with glioblastoma.
Roche is planning to discuss the phase III results with regulatory authorities around the world including the European Medicines Agency (:EMA) and the FDA. The company expects final data on overall survival and other co-primary endpoints in 2013.
We note that Avastin is currently approved in more than 30 countries worldwide including the US for the treatment of glioblastoma as a single agent and in combination with irinotecan in some countries. US approval came under the FDA’s accelerated approval program.
Roche headquartered in Basel, Switzerland, carries a Zacks #4 Rank (short-term Sell rating).
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