- Novartis' pipeline eye medicine stacked up to Regeneron's Eylea (aflibercept) in two late-stage studies, the Swiss pharma disclosed Tuesday.
- Topline results from the Phase 3 HAWK and HARRIER studies found Novartis' drug RTH258 met its primary endpoint of non-inferiority to Eylea, showing similar effects on the average change in best-corrected visual acuity (BCVA) from baseline to week 48 for patients with neovascular, or wet, age-related macular degeneration.
- Significantly, the 6 mg dose of RTH258, which investigators tested in both trials, proved to have longer-lasting efficacy than Eylea, according to a June 20 statement. More than half of the patients taking Novartis' drug in HAWK and HARRIER were on a once-every-12-week maintenance regimen, whereas investigators dosed participants receiving Eylea every eight weeks.
Novartis plans to file RTH258 for approval in 2018 following the completion of a pharmacokinetic study. Should the drug get the go-ahead from the Food and Drug Administration's, it would join the growing field of marketed products targeting vascular endothelial growth factor (VEGF), a protein that promotes blood vessel development.
VEGF inhibitors have become promising both for their ability to heal patients as well as spruce up revenues for pharmaceutical companies. The drug class is used to treat cancer, such as with Roche's Avastin (bevacizumab), and various eye diseases. Another anti-VEGF Roche drug, Lucentis (ranibizumab), has indications for wet age-related macular edema, diabetic macular edema and myopic choroidal neovascularization.
Eylea also targets VEGF, and brought in $854 million worth of net sales for Regeneron during the first quarter. The Tarrytown, N.Y.-based drugmaker has also been investigating longer regimens of the product, and plans to file for a label expansion to include 12-week dosing by the end of the year, according to a company spokesman.
"We've been on the market for a long time, so physicians are comfortable with using us," a Regeneron spokesman told BioPharma Dive. "We have a really great safety profile and efficacy profile, and that's been shown in multiple clinical trials, and all of our pivotal trials are really the largest trials for wet AMD out there. We're confident in our data, we're confident in the profile we've built over time."
Investors will get a clearer image of exactly how well RTH258 compares to Eylea when Novartis presents more late-stage data, which will come at an upcoming, unspecified medical meeting. Yet the topline results are already spurring some optimism; the big pharma's shares were up about 1% to $82.17 in Tuesday morning trading.
In addition to demonstrating non-inferiority, RTH258 benefits from showing efficacy on 12-week dosing. Like Eylea and Lucentis, Novartis' drug is administered via injections. Given the frequent struggles physicians have with keeping patients adherent, especially when the prescribed medication is an injectable, a longer-lasting option could lock down a solid segment of the wet AMD market.
To that end, Novartis has previously said it expects the drug to reach blockbuster status.
"These results clearly and convincingly demonstrate RTH258 has the potential to reduce injection burden while providing excellent visual outcomes," Vas Narasimhan, Novartis' chief medical officer, said in the June 20 statement.