Novartis Drug Galvus Shown to Be Well-Tolerated and Effective in Patients With Type 2 Diabetes and Moderate Or Severe Renal Impairment

· Galvus provides significant improvement in glycemic control, at half the dose, when added to ongoing anti-diabetic therapy in people with renal impairment1,2

· Largest study with DPP-4 inhibitors in patients with renal impairment, a high-risk group with limited therapeutic options1-4

Basel, September 14, 2011 – Novartis announced today that Galvus® (vildagliptin) has a similar safety profile to placebo when added to anti-diabetic therapy in patients with type 2 diabetes (T2DM) and moderate or severe renal impairment1,2. These results were presented at the 47th Annual Meeting of the European Association for the Study of Diabetes.

The vildagliptin study, which is the largest of a dipeptidyl peptidase-4 (DPP-4) inhibitor in patients with T2DM and moderate and severe renal impairment (n=515), also showed that vildagliptin added to current therapy resulted in significant improvements in glycemic control1,2.

“Safety is the primary concern in the treatment of patients with renal impairment and this study demonstrated strong safety results with vildagliptin, without compromising on efficacy,” said Ameet Nathwani, MD, Global Head of Cardiovascular and Metabolism Development Franchise at Novartis Pharmaceuticals. “Renally-impaired patients are a particularly vulnerable and high-risk T2DM population3 with limited therapeutic options1,2,4.”

The data showed that the overall safety and tolerability of vildagliptin 50 mg in patients with moderate or severe renal impairment were generally similar to placebo1,2. In patients with moderate renal impairment, similar proportions of those receiving vildagliptin or placebo experienced any adverse event (AE) (68% vs 73%), any serious adverse event (SAE) (9% vs 9%), any AE leading to discontinuation (3% vs 5%) or death (1% vs 1%)1,2. This was also true for patients with severe renal impairment: AEs (73% vs 74%), SAEs (19% vs 21%), AEs leading to discontinuation (9% vs 6%) and death (2% vs 4%)1,2. In the moderate renal impairment group, a slightly higher rate of hypoglycemia was seen in vildagliptin-treated patients, but in patients with severe renal impairment, the incidence of hypoglycemia was similar for vildagliptin and placebo1,2. These findings are consistent with earlier reports that vildagliptin carries a low risk of hypoglycemia2.

 

The results further revealed no clinically relevant differences between vildagliptin and placebo in the incidence of hepatic-, skin-, edema- and pancreatitis-related adverse events1,2. In patients with severe renal impairment, the incidence of infections and infestations was higher with vildagliptin than placebo, contrary to what was seen in patients with moderate renal impairment1,2. The majority of these AEs were mild or moderate1,2.

The study showed that vildagliptin elicited a statistically and clinically significant decrease in A1C (blood sugar) when added to anti-diabetic therapy, with A1C reductions of 0.7% (from baseline 7.9%) in moderate impairment and 0.9% (from baseline of 7.7%) in severe impairment1,2. Maximal efficacy was achieved with 50 mg once-daily dosing in patients with renal impairment on par with results of 50 mg twice-daily dosing experienced in patients with normal renal function2.

The Novartis-sponsored, 24-week, multi-center, randomized, double-blind, parallel-group, placebo-controlled study assessed the safety and tolerability of vildagliptin (50 mg qd) in this difficult-to-treat patient population1,2,4. The study included 294 patients with moderate renal impairment and 221 with severe renal impairment and both groups were randomized to receive vildagliptin or placebo1,2. Renal function was measured by glomerular filtration rate (GFR) and moderate and severe renal impairment were defined and estimated as GFR ≥ 30 to < 50 or < 30 mL/min/1.73m1,2.

 

Aliskiren data at EASD

Additional data of interest presented at EASD included findings from a Novartis-sponsored, pooled, retrospective analysis of 16 randomized, double-blind clinical trials involving more than 10,000 patients, examining the blood pressure lowering effects of Rasilez® (aliskiren) in hypertensive patients with diabetes5. The analysis showed that patients with hypertension and T2DM who were treated with aliskiren monotherapy showed significant dose-related reductions in systolic and diastolic blood pressure, which were similar to the blood pressure reductions seen in patients with hypertension5. The combination of diabetes and hypertension can significantly increase an individual’s risk of life-threatening cardiovascular and renal diseases6. In many patients with diabetes and hypertension an overactive renin angiotensin aldosterone system (RAAS) can affect blood pressure control and increase cardio-renal risk7,8.

About vildagliptin and aliskiren

Vildagliptin is a DPP-4 inhibitor that works by blocking the breakdown of ‘incretin’ hormones in the body that stimulate the pancreas to produce insulin9. Its mechanism of action targets the dysfunction in the pancreatic islet alpha and beta cells that cause high blood sugar levels in people with T2DM9.

The use of Galvus (vildagliptin) is not currently recommended in patients with moderate or severe renal impairment9. Vildagliptin is currently available to treat these patients only through carefully controlled and monitored clinical trials. These trials are designed to better understand the potential benefits and risks of the use of vildagliptin in this population.

Rasilez (aliskiren), known as Tekturna® in the US, is a first-in-class, innovative high blood pressure treatment that works at the point of activation of the RAAS, directly inhibiting the activity of renin, an enzyme that triggers a process that may lead to high blood pressure10.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as “commitment,” “can,” “potential,” or similar expressions, or similar expressions, or by express or implied discussions regarding potential new indications or labeling for Galvus and/or Rasilez or regarding potential future revenues from Galvus and/or Rasilez. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Galvus and/or Rasilez to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Galvus and/or Rasilez will be approved for any additional indications or labeling in any market. Nor can there be any guarantee that Galvus and/or Rasilez will achieve any particular levels of revenue in the future. In particular, management’s expectations regarding Galvus and/or Rasilez could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; the company’s ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

 

About Novartis

Novartis provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, consumer health products, preventive vaccines and diagnostic tools. Novartis is the only company with leading positions in these areas. In 2010, the Group’s continuing operations achieved net sales of USD 50.6 billion, while approximately USD 9.1 billion (USD 8.1 billion excluding impairment and amortization charges) was invested in R&D throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 121,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

 

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References

1. Kothny W, et al. Comparison of vildagliptin with placebo in a 24-week study of 221 patients with type 2 diabetes and severe renal impairment (eGFR<30). Poster 819. European Association for the Study of Diabetes 2011.

2. Lukashevic V, et al. Safety and efficacy of vildagliptin versus placebo in patients with type 2 diabetes and moderate or severe renal impairment: A prospective 24-week randomized placebo controlled trial. Diab, Obes and Metab 2011;13:947-954.

3. Thomas MC, et al. The burden of chronic kidney disease in Australian patients with type 2 diabetes (the NEFRON study). Med J Aust 2006;185:140-144.

4. Cavanaugh KL. Diabetes Management Issues for Patients With Chronic Kidney Disease. Clin Diabetes 2007;25(3):90-97.

5. Sowers JR, et al. Blood pressure lowering effects of the direct renin inhibitor aliskiren in patients with diabetes: a pooled analysis of 16 randomized trials. Poster 1106. European Association for the Study of Diabetes 2011.

6. Epstein M, et al. Diabetes Mellitus and Hypertension. Hypertension 1992;19:403-418.

7. Volpe M, et al. The Renin-Angiotensin System as a Risk Factor and Therapeutic Target for Cardiovascular and Renal Disease. J Am Soc Nephrol 2002;13(suppl 3):S173-S178.

8. Price DA, et al. The State and Responsiveness of the Renin Angiotensin-Aldosterone System in Patients with Type II Diabetes Mellitus. Am J Hypertens 1999;12(4):348-355.

9. GALVUS Summary of Product Characteristics (SmPC) for European Union.

10. RASILEZ Summary of Product Characteristics (SmPC) for European Union.

 

 

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Posted: September 2011

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