Pioglitazone ratio

Application withdrawn

The application for this medicine has been withdrawn

pioglitazone

Overview

On 3 February 2012, ratiopharm GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Pioglitazone ratio, for the treatment of type 2 diabetes.

What is Pioglitazone ratio?

Pioglitazone ratio is a medicine that contains the active substance pioglitazone. It was to be available as tablets (15, 30 and 45 mg).

Pioglitazone ratio was developed as a 'generic medicine'. This means that Pioglitazone ratio is similar to a 'reference medicine' already authorised in the European Union (EU) called Actos.

What was Pioglitazone ratio expected to be used for?

Pioglitazone ratio was to be used to treat type 2 diabetes in adults, particularly those who are overweight. It was to be used in addition to diet and exercise.

Pioglitazone ratio was to be used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable.

Pioglitazone ratio was also to be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.

How is Pioglitazone ratio expected to work?

Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. The active substance in Pioglitazone ratio, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces. As a consequence, the blood glucose levels are reduced and this helps to control type 2 diabetes.

What did the company present to support its application?

Because Pioglitazone ratio is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

How far into the evaluation was the application when it was withdrawn?

The evaluation had finished and the CHMP had given a positive opinion. The company withdrew before the European Commission had issued a decision on this opinion.

What was the recommendation of the CHMP at that time?

The CHMP concluded that, in accordance with EU requirements, Pioglitazone ratio had been shown to have comparable quality and to be bioequivalent to Actos. Therefore, at the time of the withdrawal, the CHMP had given a positive opinion, recommending that a marketing authorisation be granted for Pioglitazone ratio for the treatment of type 2 diabetes.

What were the reasons given by the company for withdrawing the application?

The withdrawal letter is available under the 'All documents' tab.

Questions and answers on the withdrawal of the marketing authorisation application for Pioglitazone ratio

Reference Number: EMA/281366/2012

Key facts

• Name of medicine:
  Pioglitazone ratio
• Active substance:
  pioglitazone
• International non-proprietary name (INN) or common name:
  pioglitazone
• Therapeutic area (MeSH):
  Diabetes Mellitus, Type 2
• EMA product number:
  EMEA/H/C/002370
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation applicant:
  Ratiopharm GmbH
• Withdrawal of application:
  03/02/2012

All documents

Withdrawal assessment report for Pioglitazone Ratio

Reference Number: EMA/391408/2012

Withdrawal letter: Pioglitazone ratio