Lucentis rival gains US approval
pharmafile | November 22, 2011 | News story | Research and Development, Sales and Marketing | Bayer, Eylea, Lucentis, Novartis, Regeneron, Roche
A rival to Roche and Novartis’ drug Lucentis has received FDA approval for a common form of eye disease.
Eylea (aflibercept) is now licensed to treat wet age-related macular degeneration (AMD), a leading cause of blindness.
The intravitreal drug is a VEGF-Eye Trap that can inhibit the binding and activation of VEGF receptors.
It is being co-developed by Bayer, which holds the rights to the drug in Europe. The firm filed for EMA approval in June this year, and expects a decision in 2012.
The drug will now compete with Roche and Novartis’ Lucentis (ranibizumab), also licensed to treat wet AMD, which has a similar mechanism of action to Eylea.
In a recent Phase III trial the drug has also shown its equivalency to Lucentis, but has so far failed to prove superiority.
But Eylea may have an edge over Lucentis as it is slightly cheaper at $1,850 per injection, compared to $1,950 for Roche and Novartis’ drug.
As it also requires fewer injections – once a month for the first three months and then bimonthly, versus monthly for Lucentis, meaning its annual cost is $8,000 less per year than Lucentis.
Lucentis made $1.4 billion in US sales last year and Eylea is forecast to reach around $1.1 billion in peak annual sales.
Jeffrey Heier, a clinical ophthalmologist and retinal specialist at ophthalmic consultants of Boston, and chair of the steering committee for the VIEW 1 clinical trial, said: “Eylea offers the potential of achieving the efficacy we’ve come to expect from current anti-VEGF agents, but with less frequent injections and no monitoring requirements.
“This may reduce the need for costly and time-consuming monthly office visits for patients and their caregivers.”
Off-label competition
But Eylea’s biggest competitor could be Roche’s cancer drug Avastin (bevacizumab), which although is not licensed to treat wet AMD, now has at least 60% of the wet AMD market, according to Bloomberg research.
This is because the drug is chemically similar to Lucentis, and is being used off-label by doctors due to its much cheaper cost of just $50 per injection.
Currently the US is funding trials to investigate whether Avastin could be routinely used for wet AMD, even though both Roche and Novartis do want the drug to gain this licence.
Ben Adams
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