Marketing Authorisation Granted for Tandemact (TM) (pioglitazone/glimepiride) for Type 2 Diabetes in Europe
- Category: Small Molecules
- Published on Thursday, 18 January 2007 02:00
- Hits: 2262
OSAKA, Japan | Jan 17, 2007 | Takeda Pharmaceutical Company Limited ("Takeda") today announced that on January 8, 2007, Takeda Global Research & Development Centre (Europe), Ltd. ("TGRD Europe") was granted a marketing authori-sation for Tandemact™, a fixed combination tablet of ACTOS® (pioglitazone HCl) and glimepiride HCl from the European Commission.
TGRD Europe submitted that application on July 29, 2005, and received a positive opinion on October 18, 2006 from The Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency ("EMEA").
ACTOS is a member of the thiazolidinedione class of "insulin-sensitizing" agents, and it directly targets insulin resistance. Glimepiride acts primarily by increasing the amount of insulin produced by the pancreas. These medications work in combination to help patients with type 2 diabetes manage their blood glucose levels. The two approved strengths for Tandemact™ are pioglitazone HCl/glimepiride 30mg/4mg and 45mg/4mg.
"We are very pleased with this approval of Tandemact™, which enables us to provide an additional treatment option for the patients with type 2 diabetes." Said Dr. Masaomi Miyamoto, General Manager of Pharmaceutical Development Division of Takeda. "And also combining these medications may provide patients with an easier way to take the two drugs, as diabetic patients are often prescribed multiple medications to help manage the disease."
Indications: Treatment of patients with type 2 diabetes mellitus who show intolerance to metformin or for whom metformin is contraindicated and who are already treated with a combination of pioglitazone and glimepiride.
Posology: The tablets are taken orally once daily shortly before or with the first main meal.The tablets should be swallowed whole with some liquid.
SOURCE: Takeda Pharmaceutical Company Limited