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December 2, 2011

Novartis gains positive CHMP opinion for vildagliptin in EU for patients with type 2 diabetes and moderate or severe renal impairment

  • Vildagliptin recommended as treatment for a diabetic patient population with significant medical need and limited therapeutic options1,2,3
  • Positive opinion based on results of largest study of a DPP-4 inhibitor in patients with renal impairment1,

Manila, October 24, 2011 – Novartis announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of vildagliptin (50 mg qd) for the treatment of patients with type 2 diabetes mellitus (T2DM) and moderate or severe renal impairment. Vildagliptin is already approved for use in patients with T2DM, including those with mild renal impairment4.

The positive recommendation is based on data from the largest study (n=515) of a dipeptidyl peptidase-4 (DPP-4) inhibitor in patients with T2DM and moderate or severe renal impairment1,2. The trial showed that vildagliptin had a similar safety profile to placebo and resulted in significant improvements in glycemic control at 50 mg qd when added to existing anti-diabetic therapy1,2.

“This positive CHMP opinion represents an important step towards offering an effective, well-tolerated therapeutic option for these difficult-to-treat patients with high unmet medical need,” said Dr. Francis Domingo, Novartis Healthcare Philippines Chief Scientific Officer.

Renal impairment affects approximately one quarter of all people with diabetes5 and like diabetes, is more common in people over 65 years of age6. Treating diabetes in patients with renal impairment can be complex as many treatments are contraindicated3.

“There are almost 4 million Filipinos with T2DM, with 500 being diagnosed everyday. Vildagliptin is a welcome additional treatment option for the growing prevalence of T2DM in the country,” said Dr. Augusto Litonjua, founder of the Philippine Society of Endocrinology and Metabolism and president of Philippine Center for Diabetes Education Foundation Inc., or Diabetes Center, Philippines.

The positive opinion is based on results of a Novartis-sponsored, 24-week, multi-center, randomized, double-blind, parallel-group, placebo-controlled study, which assessed the safety and tolerability of vildagliptin (50 mg qd)1,2. The study included 294 patients with moderate renal impairment (glomerular filtration rate (GFR) ≥30 to <50 mL/min/1.73m2) and 221 patients with severe renal impairment (GFR <30 mL/min/1.73m2)1,2. Results showed that a similar proportion of patients with moderate renal impairment in the vildagliptin group and placebo group experienced any adverse event (AE) (68% vs. 73%), any serious adverse event (SAE) (9% vs. 9%) and 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 addition, the study showed that vildagliptin elicited a statistically and clinically significant decrease in A1C (blood sugar) when added to existing 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.

About Vildagliptin
Vildagliptin is a DPP-4 inhibitor that works by blocking the breakdown of ‘incretin’ hormones in the body that stimulate the pancreas to produce insulin4. Its mechanism of action targets the dysfunction in the pancreatic islet alpha and beta cells that cause high blood sugar levels in patients with T2DM4.

Vildagliptin is indicated for the treatment of T2DM as dual oral therapy in combination with:

  • Metformin, in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin.
  • A sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose of a sulphonylurea and for whom metformin is inappropriate due to contraindications or intolerance.
  • A thiazolidinedione, in patients with insufficient glycaemic control and for whom the use of a thiazolidinedione is appropriate4.

Vildagliptin should not be used in patients with hepatic impairment and in patients with coronary heart failure and is not recommended for use in children and adolescents4.

Since becoming available, vildagliptin has been shown to be well tolerated and effective in more than 15,000 vildagliptin-treated patients as part of a large clinical development program7 and the total patient-year exposure with vildagliptin is more than two million patient-treatment years8.

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 or regarding potential future revenues from Galvus. 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 to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Galvus will be approved for any additional indications or labeling in any market. Nor can there be any guarantee that Galvus will achieve any particular levels of revenue in the future. In particular, management’s expectations regarding Galvus 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. Cavanaugh KL. Diabetes Management Issues for Patients With Chronic Kidney Disease. Clin Diabetes 2007;25(3):90-97.
  4. GALVUS Summary of Product Characteristics (SmPC) for European Union.
  5. Blicklé JF et al. Diabetic nephropathy in the elderly. Diab & Metabol 2007;33:S40-S55.
  6. Silva FG. The aging kidney: a review - part II. Int Urol Nephrol 2005;37(2):419-432.
  7. Novartis Drug Regulatory Affairs, “Scientific documentation related to the paediatric investigation plan application”, dated 15-04-2011.
  8. Novartis Data on File.