Zurich: Novartis's anti-blindness medicine Beovu has become the latest eye drug to win U.S. Food and Drug Administration approval, giving the Swiss drugmaker a boost in the increasingly competitive market for eye problems among an ageing population.
Beovu injections, given straight into the eye, treat wet age-related macular degeneration (AMD) that affects 20 million people worldwide, the Swiss drugmaker said on Tuesday.
With the FDA's blessing, Beovu joins blockbuster predecessors Lucentis, which Novartis sells with Roche, and Eylea from both Bayer and Regeneron, in the AMD market. Drugs gain blockbuster status if their sales top $1 billion.
More rivals are coming. Roche has a refillable Lucentis "port" implant as well as its drug candidate faricimab. Allergan and Swiss-based Molecular Partners have filed with U.S. and European regulators for abicipar. Lucentis and Eylea copycats are waiting in the wings for patent expirations.
Also, in Britain and elsewhere, some doctors can use Avastin, a Roche drug that works much like Lucentis, but is cheaper.
"The market for AMD is growing strongly as a consequence of an ageing population and lacking preventative procedures and is currently worth around $9 billion annually," Zuercher Kantonalbank analyst Michael Nawrath said. "In the next 10 years, the market is expected to double in size."
Beovu's list price is around $11,100 for the first year and $7,400 annually thereafter when injected by an eye doctor every three months, a level Novartis says is comparable to Eylea.
Just over half of patients in Novartis's studies maintained quarterly dosing at the one-year mark with Beovu, it said, with the rest going to dosing every two months.
Eylea is also approved for quarterly dosing, though that is not as effective as once every two months, based on instructions to doctors on how to use it.
Novartis sees Beovu as a $1 billion-plus annual seller as Lucentis and Eylea annually bring in some $3.7 billion and $4 billion respectively.
Novartis says Beovu, also known as RTH258 or brolucizumab, will capture a big slice partly because its once-quarterly injection schedule for some patients is less demanding than the once-per-month injections common with Lucentis.
"That's where for patients and caregivers it often gets extremely overwhelming," said Marie-France Tschudin, head of Novartis's main drugs division, told Reuters. "This is where Beovu comes in."
Roche sells Lucentis in the United States, Novartis sells it elsewhere in the world.
Novartis also cited studies showing Beovu to be as effective as Eylea in improving vision and better than the Bayer Regeneron-made competitor at controlling retinal fluid, a hallmark of AMD disease activity.