Despite facing a highly touted competitor in Novartis’ Beovu,
Regeneron hasn’t broken a sweat as blockbuster eye med Eylea continues
to gobble up market share. Already in the lead in multiple indications,
new two-year data could help Regeneron make the case for its drug in the
preventive setting as well.
After two years, injectable Eylea sliced the risk of vision-threatening complications by 75% over placebo in patients with non-proliferative diabetic retinopathy, according to phase 3 data released Friday.
Regeneron touted the data as a case for physicians to use Eylea preventively, as 58% of patients in the phase 3 Panorama trial’s control arm developed diabetic macular edema or compromised vision at the two-year mark.
The FDA approved
Eylea in May to treat all stages of diabetic retinopathy, a condition
that affects about 8 million people worldwide and is the leading cause
of blindness in U.S. adults, the company said.
The administration based its nod on six- and 12-month data from the Panorama study showing Eylea significantly cut the risk of patients developing proliferative diabetic retinopathy when treated every eight and 16 weeks.
Eylea’s newest data will likely give Regeneron even more confidence that its blockbuster can weather the storm as competitors like Novartis’ Beovu take on the stalwart in wet age-related macular degeneration (AMD).
In the fourth quarter, U.S. sales of Eylea jumped 13% year over year to $1.22 billion, slightly ahead of industry watchers’ expectations of $1.20 billion. Regeneron commercial chief Marion McCourt tied Regeneron’s booming success to its sustained market dominance in AMD as well as its growing penetration in diabetic eye disease. The drugmaker also rolled out a prefilled syringe application in December that McCourt said would drive volume in the future.
Also on Friday, Regeneron announced it would enroll patients in a phase 2 study of high-dose Eylea in wet AMD, potentially setting the stage for a future regulatory filing.
Those figures are good news for Eylea as Beovu, just months into its launch, hit $35 million in sales in its first quarter and has attracted some positive reviews from physicians.
In an earnings call earlier this month, Novartis said Beovu had received “outstanding feedback” so far, with 84% of retina specialists actively prescribing the drug. Evercore ISI analysts said at least one physician saw a “dramatic improvement” in patients treated with Beovu over both Eylea and a third competitor, Roche’s Lucentis.
Those positive reviews spelled dollar signs for Evecore, which said that Beovu could be well on its way to capturing half of the AMD market within the next two years.
It’s not all sunshine and roses for Beovu, though: After its approval in October, Piper Jaffray analyst Christopher Raymond called the drug’s label a “hot mess” without any Eylea-topping data included and no four-week dosing schedule. SVB Leerink analyst Geoffrey Porges had choice words of his own, blasting the Beovu label’s “lack of clarity” on dosing, including sparse language directing physicians on how to choose between eight- and 12-week schedules.
https://www.fiercepharma.com/pharma/regeneron-builds-preventative-case-for-eylea-new-2-year-data
After two years, injectable Eylea sliced the risk of vision-threatening complications by 75% over placebo in patients with non-proliferative diabetic retinopathy, according to phase 3 data released Friday.
Regeneron touted the data as a case for physicians to use Eylea preventively, as 58% of patients in the phase 3 Panorama trial’s control arm developed diabetic macular edema or compromised vision at the two-year mark.
The administration based its nod on six- and 12-month data from the Panorama study showing Eylea significantly cut the risk of patients developing proliferative diabetic retinopathy when treated every eight and 16 weeks.
Eylea’s newest data will likely give Regeneron even more confidence that its blockbuster can weather the storm as competitors like Novartis’ Beovu take on the stalwart in wet age-related macular degeneration (AMD).
In the fourth quarter, U.S. sales of Eylea jumped 13% year over year to $1.22 billion, slightly ahead of industry watchers’ expectations of $1.20 billion. Regeneron commercial chief Marion McCourt tied Regeneron’s booming success to its sustained market dominance in AMD as well as its growing penetration in diabetic eye disease. The drugmaker also rolled out a prefilled syringe application in December that McCourt said would drive volume in the future.
Also on Friday, Regeneron announced it would enroll patients in a phase 2 study of high-dose Eylea in wet AMD, potentially setting the stage for a future regulatory filing.
Those figures are good news for Eylea as Beovu, just months into its launch, hit $35 million in sales in its first quarter and has attracted some positive reviews from physicians.
In an earnings call earlier this month, Novartis said Beovu had received “outstanding feedback” so far, with 84% of retina specialists actively prescribing the drug. Evercore ISI analysts said at least one physician saw a “dramatic improvement” in patients treated with Beovu over both Eylea and a third competitor, Roche’s Lucentis.
Those positive reviews spelled dollar signs for Evecore, which said that Beovu could be well on its way to capturing half of the AMD market within the next two years.
It’s not all sunshine and roses for Beovu, though: After its approval in October, Piper Jaffray analyst Christopher Raymond called the drug’s label a “hot mess” without any Eylea-topping data included and no four-week dosing schedule. SVB Leerink analyst Geoffrey Porges had choice words of his own, blasting the Beovu label’s “lack of clarity” on dosing, including sparse language directing physicians on how to choose between eight- and 12-week schedules.
https://www.fiercepharma.com/pharma/regeneron-builds-preventative-case-for-eylea-new-2-year-data
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