Withdrawal of the Marketing Authorisation Application for Balugrastim

On 4 November 2014, Teva Pharma B.V. officially notified the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for balugrastim (Egranli), for reduction in the duration of neutropaenia and the occurrence of febrile neutropaenia in adult cancer patients.

What is balugrastim?

Egranli is a medicine that contains the active substance balugrastim. It was to be available as a solution for injection in prefilled syringes.

What was balugrastim expected to be used for?

Balugrastim was to be used to reduce the duration of neutropaenia and the occurrence of febrile neutropaenia in adult cancer patients receiving cytotoxic chemotherapy.

How is balugrastim expected to work?

The active substance in Egranli, balugrastim, is made up of granulocyte-colony-stimulating factor (G-CSF), a naturally occurring protein in the body that promotes the production of white blood cells including neutrophils in the bone marrow. The G-CSF in Egranli is attached to another natural blood protein, albumin, which decreases the rate at which G-CSF is removed from the body and allows the medicine to have a longer duration of action and to be given less often.

Balugrastim acts in the same way as naturally produced G-CSF, increasing the production of neutrophils and thereby helping to reduce the duration of neutropaenia and to prevent febrile neutropaenia in patients undergoing chemotherapy.

What did the company present to support its application?

Balugrastim was investigated in a main study in 304 breast cancer patients receiving chemotherapy, in which it was compared with another medicine containing a different long-acting G-CSF, pegfilgrastim. The main measure of effectiveness was the reduction in the duration of neutropaenia and of the number of febrile neutropaenia cases.

How far into the evaluation was the application when it was withdrawn?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

Based on the review of the data, at the time of the withdrawal, the CHMP had given a positive opinion, recommending that a marketing authorisation be granted for balugrastim for the reduction of the duration of neutropaenia and of the occurrence of febrile neutropaenia.

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

In its letter notifying the Agency of the withdrawal of application, the company stated that it was withdrawing the application on the basis of its marketing strategy, and that it wished to focus on other projects.

What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?

The company informed the CHMP that there is no impact on patients as there are no ongoing clinical trials or compassionate use programmes using balugrastim.