Ibandronic Acid Hexal

Application withdrawn

The application for this medicine has been withdrawn

ibandronic acid

Overview

On 21 July 2011, Hexal AG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ibandronic Acid Hexal, for the prevention of skeletal events in patients with breast cancer and bone metastases.

What is Ibandronic Acid Hexal?

Ibandronic Acid Hexal is a medicine that contains the active substance ibandronic acid. It was to be available as white tablets.

Ibandronic Acid Hexal was developed as a 'generic medicine'. This means that Ibandronic Acid Hexal was intended to be similar to a 'reference medicine' already authorised in the European Union called Bondronat.

What was Ibandronic Acid Hexal expected to be used for?

Ibandronic Acid Hexal was to be used to prevent 'skeletal events' (fractures [broken bones] or bone complications requiring treatment) in patients with breast cancer and bone metastases (when the cancer has spread to the bone).

How is Ibandronic Acid Hexal expected to work?

Ibandronic Acid Hexal is expected to work in the same way as the reference medicine, Bondronat. The active substance in Ibandronic Acid Hexal and Bondronat, ibandronic acid, is a bisphosphonate. It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue. This leads to less bone loss. The reduction of bone loss helps to make bones less likely to break, which is useful in preventing fractures in cancer patients with bone metastases.

What did the company present to support its application?

Because Ibandronic Acid Hexal was developed as a generic medicine, the company presented the results of studies carried out to investigate whether it is 'bioequivalent' to the reference medicine. 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How far into the evaluation was the application when it was withdrawn?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, Ibandronic Acid Hexal had been shown to have comparable quality and to be bioequivalent to Bondronat. Therefore, the CHMP's view was that, as for Bondronat, the benefit outweighs the identified risk. The Committee recommended that Ibandronic Acid Hexal be given marketing authorisation.

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

The letter from the company notifying the Agency of the withdrawal of the application is available under the tab 'All documents'.

Questions and answers on the withdrawal of the marketing authorisation application for Ibandronic Acid Hexal

Reference Number: EMA/685524/2011

Key facts

• Name of medicine:
  Ibandronic Acid Hexal
• Active substance:
  ibandronic acid
• International non-proprietary name (INN) or common name:
  ibandronic acid
• Therapeutic area (MeSH):
  • Hypercalcemia
  • Breast Neoplasms
  • Osteoporosis
  • Neoplasm Metastasis
• Anatomical therapeutic chemical (ATC) code:
  M05BA06
• EMA product number:
  EMEA/H/C/002366
• 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:
  Hexal AG
• Withdrawal of application:
  21/07/2011

All documents

Withdrawal assessment report for Ibandronic Acid Hexal

Adopted Reference Number: EMA/CHMP/90168/2011

Withdrawal letter: Ibandronic Acid Hexal