With Libtayo now squarely in Regeneron’s hands, the drugmaker is eager to start cranking out combination therapies. But one near-term prospect is expected to suffer a delay.
Regeneron’s Libtayo-chemotherapy combo in advanced squamous or nonsquamous non-small cell lung cancer is unlikely to clinch approval until after its FDA action date next month, Regeneron’s CEO said on a call with investors Wednesday.
While the company is “pleased” with the progress the FDA’s made so far on its review of the Libtayo lung cancer combo, “we recently were informed that an FDA travel complication relating to scheduling a routine clinical trial site inspection in Eastern Europe will likely delay their decision until after our September 19 PDUFA date,” Regeneron helmsman Len Schleifer, M.D., Ph.D., said on the call.
The delay should be brief, Schleifer stressed. A new site inspection has been scheduled, and Regeneron does “not expect a lengthy extension of review period,” Schleifer said. The delay would not “meaningfully impact our launch plans, assuming FDA approval," he added.
Back in June, Regeneron laid out $900 million to pick up exclusive worldwide rights to Libtayo from its partner Sanofi. With rights to the drug, the company "will have the freedom to explore combination opportunities in our pipeline with existing collaborators and with future partners, while realizing a greater share of the potential upside from these investments," Schleifer said earlier this summer.
Meanwhile, the FDA inspection update came as Regeneron’s second quarter revenues slipped a whopping 44% to $2.86 billion.
Even still, that precipitous decline doesn’t tell the whole story. Taking sales of the company’s COVID-19 antibody cocktail REGEN-COV out of the mix, revenues increased 20% versus the same period in 2021, Regeneron said in a release.
REGEN-COV once formed part of the front-line of pandemic therapeutics. In January, however, the FDA tweaked the med’s emergency nod and pulled REGEN-COV from the U.S. market over concerns of waning efficacy in the face of the surging Omicron variant.
More recently, Regeneron axed four trials of the med across a range of patients and clinical stages. It credited the study cull to “[e]merging SARS-CoV-2 variants impacting susceptibility to study drug,” recent updates on ClinicalTrials.gov state.
With its main COVID-19 drug sidelined, the company is relying on bread-and-butter meds like Eylea and Dupixent to carry its top line.
Immunology superstar Dupixent, which Regeneron shares with Sanofi, posted a 40% revenue increase to reach $2.09 billion in sales for the second quarter.
Last week, Sanofi pointed out that it’s treated more than 450,000 patients worldwide with Dupixent since the drug’s launch. Even still, “we know that it’s only really starting at this point,” Sanofi CEO Paul Hudson said of Dupixent’s future trajectory. Sanofi recently boosted its peak sales target for Dupixent from 10 billion euros to more than 13 billion euros (about $14.44 billion). Readouts in chronic obstructive pulmonary disease next year could drive that sales potential even higher.
Originally cleared in the U.S. back in 2017 for eczema, Dupixent has since won green lights in three diseases across multiple age groups. This year, the med racked up wins in atopic dermatitis, severe asthma and an approval as the first medication to treat eosinophilic esophagitis.
Bayer-partnered Eylea, for its part, pulled down record revenues of $1.62 billion in the U.S., a 14% jump over the sum it earned for the period in 2021, Regeneron said.
Editor's note: An earlier version of this story raised the question of whether the war in Ukraine contributed to the FDA delay. A Regeneron spokesperson said that the delay has "nothing to do" with Ukraine.