|Regeneron Announces FDA Approval of EYLEA; Mylan Launches First Generic of Novartis' Diovan|
|By Staff and Wire Reports|
|Friday, 21 September 2012 18:43|
Regeneron Pharmaceuticals (NASDAQ: REGN) announced that the U.S. FDA has approved EYLEA® (aflibercept) Injection for the treatment of Macular Edema following Central Retinal Vein Occlusion (CRVO). The recommended dose for EYLEA is 2 milligrams (mg) every 4 weeks (monthly).
"This second U.S. approval for EYLEA provides physicians and patients with a new treatment option for the treatment of macular edema following CRVO," stated George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. "Based upon the pivotal Phase 3 study results, EYLEA has been shown to significantly improve visual outcomes in a disease characterized by high VEGF levels. We thank the patients and clinical investigators who participated in our clinical studies, the FDA, and the Regeneron employees who helped make this day possible."
The approval of EYLEA for Macular Edema following CRVO was based on data from the Phase 3 COPERNICUS and GALILEO studies. In both studies, the primary efficacy endpoint was the proportion of patients who gained at least 15 letters of Best Corrected Visual Acuity (BCVA) at 24 weeks compared to baseline as measured by ETDRS. Results for the EYLEA 2 mg monthly group were superior to those for the sham control group for the primary endpoint.
EYLEA is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in EYLEA.
Mylan Inc. (Nasdaq: MYL) announced its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for Valsartan and Hydrochlorothiazide Tablets USP, 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg.
This product is the generic version of Novartis' Diovan HCT^® Tablets, which are indicated for the treatment of hypertension, to lower blood pressure in patients not adequately controlled with monotherapy or as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.
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