Medtronic (NYSE:MDT) has plans to submit its MiniMed 780G for an expanded indication from the FDA for type 2 diabetes in the near future.
On the company’s second-quarter earnings call, Que Dallara, EVP and president of Medtronic Diabetes outlined the progress on that front.
“We’ve finished enrollment [in a study of MiniMed 780G for type 2 diabetes],” Dallara said. “We expect to submit to the FDA for expanded indication in the first half of the next calendar year. So, that’s progressing very well.”
Automated insulin delivery (AID) has historically catered to the type 1 diabetes population, but a number of companies are pursuing expanded indications for their technology, like Medtronic.
Insulet won the race, so to speak, earning FDA clearance for its Omnipod 5 system for type 2 diabetes in August. Clearance made Omnipod 5, the company’s latest-generation AID system, the first and only such system cleared for type 1 and type 2 diabetes. Tandem Diabetes Care said earlier this month that it recently completed a clinical study in support of a regulatory filing to expand the indication for its Control-IQ automated insulin dosing technology to include people with type 2 diabetes.
“We’re still largely a type 1 business,” Dallara noted. “We do see type 2 as being quite a large opportunity. The clinical data that we’ve generated for type 2 is extremely good, so we are quite optimistic about the type 2 opportunity.”
Medtronic also updates on patch pump progress
The medtech giant was set to enter the patch pump space currently led by Insulet late last year with a $738 million acquisition of EOFlow. However, about six months after striking that deal, the company called it off, citing multiple breaches of their acquisition agreement.
Reports surfaced in Korea not long after the deal fell through saying that mutual interest remained between companies. However, Medtronic also said at the time that it has its own differentiated patch pump under development.
On the earnings call, Martha said the company’s patch pump programs “remain dynamic.”
“We’ve got a couple of shots on goal, there,” he said. “I don’t believe we’ve given any timing on that, other than that we’ve been investing heavily in diabetes across the entire [ecosystem]. One of our strengths is that we have the entire ecosystem, and a patch needs to be a part of that. We’ve got a couple shots on goal here, but we’re not giving timing on that.”