The US Food & Drug Administration (FDA) recently approved
Roche Holdings Ltd.
) 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
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
Roche headquartered in Basel, Switzerland, carries a Zacks #4
Rank (short-term Sell rating).
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