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ADA conference: Boehringer-Lilly plan 2013 filing for diabetes drug empagliflozin

Also expect to release further safety data on SGLT2 inhibitor by the end of the year

American Diabetes Association (ADA) Philadelphia meeting 2012

Boehringer Ingelheim and Eli Lilly & Company are preparing to submit their new type 2 diabetes drug empagliflozin to US and European regulators for approval next year.

The SGLT2 inhibitor drug is one of four late-stage candidates included in the pharma companies' 2011 alliance. The partners have already seen success with their DPP-4 inhibitor Trajenta (linagliptin), which was approved in the US and Europe last year.

Empagliflozin is one of a number of SGLT2 inhibitors vying to be the first to reach the market, with Janssen's canagliflozin so far the most advanced.

Janssen's drug was accepted by the US Food and Drug Administration (FDA) earlier this month, giving the company an advantage over AstraZeneca and Bristol-Myers Squibb, whose Forxiga (dapagliflozin) was knocked back earlier this year when the regulator asked for more clinical data with the drug linked to bladder and breast cancer.

Speaking to PMLiVE in Philadelphia at the American Diabetes Association's (ADA) annual meeting Dr Thomas Seck, Boehringer's associate European area head for metabolism, outlined the timeline his company hope to follow for empagliflozin.

"We expect that we will have [phase III] data available by the end of this year and therefore we should be able to submit an application next year.

"We would try to do both [US and European filings] in a very similar time frame," he said, but refused to be drawn on when in 2013 this might be.

Empagliflozin is currently in clinical trials involving over 14,500 patients in what Boehringer said is the largest ever phase III programme in diabetes.

He also said the company expected to be able to release by the end of this year more phase III safety data for the drug, which would include addressing its relation to incidences of cancer.

Dr Seck said: "It's a huge programme that really was done because we wanted to assess the safety and efficacy of this compound very thoroughly. As part of any clinical study, that's true for SGLT2 inhibitors, but also for DDP-4 inhibitors, you also capture all sorts of cancers. That is reported by the investigators and reported in our database, so we will be able to fully address this concern once we have our data from phase III."

At the ADA meeting Boehringer and Lilly presented study results that showed empagliflozin, used by itself or as an add-on to metformin, reduced haemoglobin A1c (HbA1c) levels, fasting plasma glucose (FPG) and body weight when given to adults with type 2 diabetes for up to 90 weeks.

In the study, 659 adults with type 2 diabetes who participated in one of two 12-week phase IIb empagliflozin trials were treated for an additional 78 weeks with 10mg or 25mg of empagliflozin (monotherapy or add-on to metformin), metformin alone, or sitagliptin as add-on to metformin.

At week 90, decreases from baseline in mean HbA1c levels (per cent), and body weight (kg) were observed with empagliflozin 10mg alone (-0.34 per cent; -2.24kg) and 25 mg alone (-0.47 per cent; -2.61kg), versus metformin alone (-0.56 per cent, -1.28kg).

When used as an add-on to metformin, decreases from baseline in mean HbA1c levels and body weight were observed with empagliflozin 10mg (-0.34 per cent; -3.14kg) and 25mg (-0.63 cent; -4.03kg), versus Merck & Co's DPP-4 inhibitor Januvia (sitagliptin) with -0.40per cent; -0.41 kg. At both 10mg and 25mg doses empagliflozin was generally well-tolerated when given for a treatment duration of up to 90 weeks.

Between 0.9 and 3.6 per cent of patients on empagliflozin reported hypoglycaemic events, versus 7.1 per cent on metformin only and 5.4 per cent on sitagliptin.

Adverse events related to urinary tract infections were reported in 3.8 to 12.7 per cent of patients on empagliflozin, 3.6 per cent of patients on metformin only, and 12.5 per cent of patients on Januvia. Adverse events related to genital infections were reported in 3.0 to 5.5 per cent of patients on empagliflozin, 1.8 per cent of patients on metformin only, and none of the patients on Januvia.

"The safety here was overall pretty favourable. The incidence of adverse events was similar with empagliflozin compared to the comparators in this study. There was a higher incidence of genital infections,  which is not unexpected for that class and was reported for other members of the class as well," Dr Seck said.

"Looking at the more serious urinary tract infections we did not see a major difference between empagliflozin and the comparators in the study," he added.

An estimated 366m people worldwide have diabetes and type 2 is by far the most prevalent, accounting for an estimated 90 per cent of all cases.

Type 2 diabetes is characterised by three main factors: persistent hyperglycaemia, impaired insulin secretion and increased insulin resistance.

Sodium glucose co-transporter-2 (SGLT-2) inhibitors like empagliflozin lower high blood glucose levels (hyperglycaemia) independently of insulin by blocking glucose re-uptake in kidneys and thereby excreting excess glucose via the urine. This results in lowering HbA1c and weight irrespective of beta cell function or insulin resistance.

11th June 2012

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