2010年11月22日 星期一

黃斑部病變患者有福了,便宜的新藥要上市了 BY I

黃斑部病變不用再靠 Lucentis  了,馬上就有另外的aflibercept 上市
造福大家了

Bayer/Regeneron's 公司的aflibercept  進入臨床三期,預計用量將少於上市的Lucentis且更具效果

Bayer/Regeneron's VEGF Trap-Eye (aflibercept) has been shown to be similar to Genentech/Novartis's Lucentis (ranibizumab) in maintaining vision, with less dosing frequency, in two head-to-head phase III trials of the two intravitreal injections for wet age-related macular degeneration (AMD).
But even though analysts are predicting VEGF Trap-Eye peak sales of $2 billion (a level of sales that Lucentis achieved last year), the commercial outcomes are likely to be influenced by results due early in 2011 from the NIH-sponsored CATT trial, a comparison of Lucentis and Roche's VEGF-targeting anticancer Avastin (bevacizumab).
Bayer and Regeneron are planning to submit regulatory applications for marketing approval of VEGF Trap-Eye in the EU and US, respectively, in the first-half of 2011 based on the results of the VIEW 1 and VIEW 2 trials.
"The results of the VIEW studies indicate that VEGF Trap-Eye could establish a new treatment paradigm for the management of patients with wet AMD --- predictable every-other-month dosing without the need for intervening monitoring or dosing visits,” said Dr Ursula Schmidt-Erfurth, chair of the department of ophthalmology at the University Eye Hospital in Vienna, Austria and the VIEW 2 principal investigator.


Lucentis, a VEGF-inhibitor which was approved in the US in 2006, revolutionised the treatment of wet AMD, the leading cause of leading cause of blindness in those over 65 in the US and Europe. Rather than just slow vision loss, the drug showed that it could improve vision; about one-third of patients in clinical trials demonstrated improved vision after 12 months.
VEGF Trap-Eye is a fully human fusion protein, consisting of soluble VEGF receptors 1 and 2, that binds all forms of VEGF-A along with the related Placental Growth Factor (PlGF); both VEG-A and PlGF are angiogenic factors which stimulate the growth of new blood vessels. In wet AMD, new blood vessels grow beneath the retina and leak blood and fluid. This leakage causes disruption and dysfunction of the retina creating blind spots in central vision.

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