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.
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.
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