Novartis is rolling out new data that build on its case for the company’s blockbuster hopeful RTH258, an investigational therapy that might carve away a considerable chunk of Regeneron’s $5 billion Eylea franchise if approved.
The new data, which came from a secondary analysis of two Phase III trials, show a compelling case for the drug as a treatment for wet age-related macular degeneration. The drug already showed impressive success in those trials last fall, when it performed well in a head-to-head comparison to Eylea. Simply put, Novartis’ CEO Vas Narasimhan said the drug was “consistently superior” to its Regeneron rival.
Now, Novartis is calling attention to RTH258’s convenience factor compared to Eylea and other therapies.
“Ever since Lucentis was first introduced more than 10 years ago as a monthly injection, physicians have been trying to find a way to space out treatments,” said Dirk Sauer, head of Novartis’ ophthalmology unit. “They’re trying to find a way to reduce the burden for the patient, but also to reduce the burden for the physician — they have lots of patients coming back every month for injections.”
Regeneron’s Eylea can be taken once every 8 weeks, which is nicer for patients and docs, but Novartis plans to go a step further. The company is betting that its 12-week regimen will win over a big slice of the market. In the data rolled out today, Novartis said patients in the trials had an 87% and 83% probability of successfully continuing a 12-week interval through week 48.
That’s big, Sauer said, considering Regeneron and others’ apparent difficulty with this dosing schedule. Not to be outdone, Regeneron told Endpoints News back in November that it was testing its own 12-week treatment cycle with Eylea. I checked back with Regeneron last week, and a company spokesperson said Regeneron’s sBLA for its 12-week Eylea treatment was accepted by the FDA and has a PDUFA date of August 11.
But Sauer said that doesn’t necessarily steal Novartis’ edge.
“I can’t speculate on the FDA label for Eylea or for ours, but the data are not the same,” Sauer said. “We did a prospective analysis, while they went back and did a retrospective analysis. Retrospective analyses, from an analytical and statistical point of view, are weaker.”
Plus, Sauer said, Regeneron doesn’t have 12-week treatment data from its first year, only its second. In the third year, the company went back to an 8-week regimen, Sauer said, which might mean patients lost visual acuity.
Still, Regeneron may be slightly ahead in the race for approval. Sauer said RTH258 should be filed with the FDA later this year. But it could take a year to 18 months for the drug actually reaches the market.
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