Eylea's PANORAMA data give fuller view of efficacy in label expansion bid
- Significantly fewer patients with advanced forms of a diabetic eye disease experienced vision-threatening events when taking Regeneron Pharmaceuticals' Eylea rather than a sham treatment, according to one-year data from the PANORAMA study released Saturday.
- The study enrolled non-proliferative diabetic retinopathy (NPDR) patients who don't have diabetic macular edema (DME) into one of three groups. In a sham treatment arm, 53% of patients with severe NPDR had a vision-threatening event, compared to 15% in each of the experimental arms, which respectively administered Eylea every eight and 16 weeks after an initial dosing period.
- Moderately severe NPDR patients also fared better when taking Eylea. Among that subgroup 36% in the sham arm had a vision-threatening event versus 8% in the 16-week Eylea arm and 10% in the eight week Eylea arm. Regeneron submitted an application for Eylea in NPDR patients without DME last year, and expects a decision from the Food and Drug Administration by May 13.
Eylea (aflibercept) is already a massive success for Regeneron and its co-development partner Bayer. For 2018, the big biotech recorded $6.75 billion worth of net sales, representing a 14% increase from the year prior.
The sales stem from two approved indications: wet age-related macular degeneration and DME. Breaking into the diabetic retinopathy market would position Eylea for even more growth, according to Regeneron, which estimates about 3.5 million people in the U.S. have the disease without DME. A study from 2012 published in the journal Diabetes Care concluded that roughly one-third of the diabetes population has diabetic retinopathy.
PANORAMA will be key to whether Eylea gets that label expansion.
Regeneron announced topline data from the Phase 3 trial in October. The data found that after an initial dosing period, 80% of participants receiving Eylea every eight weeks and 65% of participants receiving it every 16 weeks had a two-step or greater improvement on a disease measurement tool called the Diabetic Retinopathy Severity Scale. In the sham group, 15% of patients experienced such an improvement.
Early results also found 41% of patients in the sham group experiencing vision-threatening events, meaning they had a vision‑threatening complication such as proliferative diabetic retinopathy or anterior segment neovascularization, or they had a central‑involved diabetic macular edema. Meanwhile, 11% of the eight-week Eylea arm and 10% of the 16-week Eylea arm experienced vision-threatening events.
The one-year data released Saturday indicates Eylea's benefit extends to advanced NPDR patients, a subgroup Regeneron says need quick and effective therapy.
"Contrary to the perception of some that diabetic retinopathy is a slowly evolving condition, our PANORAMA study demonstrated that patients with moderately severe or severe diabetic retinopathy may progress rapidly developing vision-threatening complications or new onset DME," Geogre Yancopoulos, the company's president and chief scientific officer, said during a Feb. 6 earnings call.
Regeneron executives did admit on the call that even with another approval, it will take a lot of patient education and some time to develop the market before NPDR meaningfully contributes to Eylea's growth story.
The company expects SG&A expenses to increase in 2019, partially because of greater Eylea spending as it relates to NPDR.
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