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12:00 AM
 | 
Jun 27, 2011
 |  BioCentury  |  Strategy

Setting Eylea's sights

Eylea's success in AMD tied to Regeneron's pricing vs Lucentis, Avastin

The fact that doctors are using Avastin bevacizumab and Lucentis ranibizumab less often than their recommended once-monthly dosing to treat wet AMD has the potential to work both for and against Regeneron Pharmaceuticals Inc.'s bi-monthly Eylea aflibercept.

On one hand, some physicians are becoming more comfortable prescribing Avastin and Lucentis less frequently, potentially blunting Eylea's dosing advantage. On the other, their comfort with experimenting with Avastin and Lucentis dosing could carry over to experimenting with even less frequent dosing of Eylea.

The missing variable is Eylea's price, which Regeneron hasn't disclosed. Avastin's price tag is $50 per dose, whereas Lucentis' is $2,000. If Eylea's price is at or above that of Lucentis, initial use of the compound is likely to be limited to patients who don't respond to the two anti-VEGF drugs.

"Interest in using Eylea will depend on the price," said Dean Eliott, a retina surgeon at the Massachusetts Eye and Ear Infirmary. "If it is extraordinarily expensive, it may be used less or not at all; if it is cheap, it could get used almost exclusively."

A new Ey-ra

On June 17, FDA's Dermatologic and Ophthalmic Drugs Advisory Committee voted 10-0 that the available safety and efficacy data are adequate for approval of Eylea to treat wet age-related macular degeneration.

Eylea (formerly VEGF Trap-Eye) is a human fusion protein that contains the extracellular domains of two VEGF receptors linked to the Fc portion of human IgG. The molecule binds all forms of vascular endothelial growth factor A (VEGF-A) and placental growth factor (PIGF).

The mAb fragment Lucentis and the mAb Avastin bind VEGF-A. Novartis AG and Genentech Inc., a unit of Roche, market Lucentis for wet AMD. Genentech's Avastin is used off-label in the indication.

The composition of Eylea allows it to bind VEGF-A more tightly than Lucentis, thus allowing for less frequent dosing. Regeneron's BLA is supported by 52-week data from the VIEW 1 and 2 trials, which showed a bi-monthly dosing regimen was non-inferior to monthly Lucentis (see BioCentury, Dec. 6, 2010).

The VIEW trials compared 0.5 mg Lucentis...

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