Boehringer Ingelheim and Lilly have confirmed that they expect an FDA decision on their diabetes drug empagliflozin by the end of the year after addressing concerns about the drug’s manufacturing.
Speaking to PMLiVE, Boehringer’s senior medical director Thomas Hach said the partners have overcome the concerns outlined in a warning letter sent by the FDA in March, which had requested Boehringer improve deficiencies at the drug’s manufacturing site in Germany.
“We expect an FDA action date within this year,” said Hach. “Things are in good shape.”
Hach was speaking at the recent American Diabetes Association meeting in San Francisco, where Boehringer and Lilly presented further data on empagliflozin, an SGLT-2 inhibitor which was recently approved under the brand name Jardiance in the EU and is due for launch later this year.
Significant study results included one trial that demonstrated the drug’s superiority to standard type 2 diabetes treatment glimepiride when both were evaluated as an add-on to metformin. This included a superior ability to decrease blood sugar levels, as well as recording lower weight gain and rates of hypoglycaemia.
Hach also explained that empagliflozin is currently being compared to Merck & Co’s DPP-4 inhibitor Januvia (sitagliptin) when each is used as a monotherapy. According to Hach, an exploratory analysis of the data indicates that empagliflozin is the superior product.
Add to this the positive results from a trial investigating the drug’s use as an add-on to treatment with a basal bolus insulin and empagliflozin has the potential to be used “over the whole treatment continuum”, said Hach.
The drug is the third diabetes treatment approved in Europe as part of the alliance between Boehringer and Lilly. The others are the DPP-4 inhibitor Trajenta (linagliptin) and Jentadueto, a combination of Trajenta and metformin.
The companies have faced problems bringing Trajenta to market in some areas, however, including in Boehringer’s home nation of Germany where the country’s health technology assessment (HTA) body IQWiG refused to back the drug for reimbursement on the healthcare system at a price with which Boehringer and Lilly were happy.
Hach declined to be drawn on whether empagliflozin would face a similar fate, although he did say the drug “will launch in Germany”. IQWiG assessments are usually completed one year after the launch of a drug, during which time it can be sold at a price set by the manufacturer.
Empagliflozin is also being assessed as part of two potential combination therapies, details of which were also presented at the ADA meeting.
As with other SGLT-2 inhibitors, including AstraZeneca’s Forxiga (dapagliflozin) and Janssen’s Invokana (canagliflozin), Boehringer is working on a combination treatment bringing empagliflozin and metformin together in one product. The benefits are obvious, according to Hach: “They add convenience … you don’t forget the other pills and you have patient convenience.”
Also of note is the potential combination of empagliflozin and Trajenta, with each drug working in a different, complementary way to lower blood sugar levels. Phase III trials presented at ADA demonstrate that more than half of the 494 adults with type 2 diabetes treated with the combination were able to achieve blood glucose goals below 7.0 per cent.
The results put the drug on course to be the first SLGT-2/DPP-4 combination filed for approval, although where the drug fits on the treatment pathway for type 2 diabetes is still something that needs to be worked out, according to Hach.
“It’s definitely an excellent combination after metformin,” he said. “Theoretically you could use it early on, but there are different treatment patterns. It’s for the physician to choose because physicians know their patients best.”