- Type 2 diabetes patients who took Eli Lilly's Trulicity experienced significantly fewer major heart problems than those who didn't, according to newly released topline data from the Phase 3 REWIND study.
- REWIND enrolled nearly 10,000 patients to test whether Trulicity beat out placebo on a composite endpoint of cardiovascular death, non-fatal heart attack and non-fatal stroke. Just over 30% of participants had established cardiovascular disease — a percentage Lilly notes is much lower than cardiovascular outcomes trials of rival therapies and reflective of the drug's usefulness across a "broad range" of Type 2 diabetes patients.
- The initial readout didn't go into detail about how much each of those composite pieces contributed to the overall reduction in major adverse cardiovascular events. Still, Wall Street analysts explained the initial, positive results help differentiate Trulicity in a crowded market. Investors responded accordingly, sending the company's shares up 3% Monday morning.
Pricing pressures and stiff competition have slammed the diabetes drug market in recent years. The trend has been especially taxing for insulins, yet newer classes of treatment have proven vulnerable too.
One of those classes are GLP-1 therapies, which mimic the blood sugar-regulating hormone Glucagon-like peptide 1. There are six GLP-1 agonists already approved by the Food and Drug Administration, including Trulicity (dulaglutide), Novo Nordisk's Victoza (liraglutide) and AstraZeneca's Byetta (exenatide).
Trulicity has fared better than its peers, however, due in large part to rapid uptake since its approval in 2014. Earlier this year, it edged out Victoza to take the lead in weekly total prescriptions among GLP-1 medicines in the U.S. For the week of Oct. 26, total Trulicity prescriptions were 104,259 while new prescriptions reached 38,310, according to Iqvia data cited by investment bank Leerink.
To that end, Trulicity has offset declines in other parts of Lilly's endocrinology portfolio. Over the first six months of 2018, Lilly recorded $1.46 billion in revenue from the drug, a 71% increase from the same period in 2017. Total endocrinology revenue also rose 22% year over year.
Yet in spite of the early success, Lilly can't afford to sit idle. Novo has been rolling out a direct-to-consumer campaign for another GLP-1 agonist, Ozempic (semaglutide), as well as a stream of positive data for an oral version of the drug.
"This is clearly positive news and should ease concerns about Trulicity's ability to compete in the rapidly-growing GLP-1 market," Credit Suisse analyst Vamil Divan wrote in a Nov. 5 note on the REWIND data.
"While a negative readout has been a key concern for us, we believe that many investors (especially long-only investors) had largely moved past a potential negative readout given the recent encouraging data from the pipeline GIP/GLP-1 co-agonist LY3298176," Divan added.
The REWIND study kicked off in mid-2011. As such, the median follow-up was more than five years, which Lilly pointed out is the longest for a cardiovascular outcome trial of a GLP-1 receptor agonist.
"One of the differences for REWIND versus other trials is the time the patients are going to be on the product. This is not a short product; it's fairly long," Enrique Conterno, president of Lilly Diabetes, said on the company's second quarter earnings call.
Lilly intends to file the REWIND data with regulators in 2019 and present more compete results at the American Diabetes Association's next Scientific Sessions conference.