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  1. Home
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  3. Macugen - withdrawal of application for variation to marketing authorisation

Macugen - withdrawal of application for variation to marketing authorisation

Application withdrawn

The application for a change to this medicine's authorisation has been withdrawn.

pegaptanib
Post-authorisationHuman

Page contents

  • Overview
  • Key facts
  • Documents
  • Related information on withdrawals
  • More information on Macugen

Overview

On 15 July 2011, Pfizer officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication, the treatment of visual impairment due to diabetic macular oedema.

Macugen is a solution for injection into the eye that contains the active substance pegaptanib. It is available as a prefilled syringe.

Macugen has been authorised since January 2006. It is already used to treat patients with the 'wet' form of age-related macular degeneration (AMD). This disease affects the central part of the retina (called the macula) at the back of the eye and causes loss of 'straight-ahead' vision.

Macugen was also expected to be used to treat visual impairment in patients with diabetic macular oedema (DME). This is the swelling of the macular caused by diabetes.

In diabetic macular oedema, Macugen is expected to work in the same way as it does in its existing indication. The active substance in Macugen, pegaptanib, is an 'aptamer'. An aptamer is a single strand of molecules called nucleotides that has been designed to attach to a structure in the body. Pegaptanib has been designed to attach to a substance called vascular endothelial growth factor (VEGF) and to block its action. In the body, VEGF is involved in the growth of blood vessels and in making them more permeable. Pegaptanib injected into the eye blocks VEGF. This reduces the growth of blood vessels and controls the leakage and swelling.

The applicant presented an overview of the effects of Macugen in experimental models from previous studies as well as some additional data.

The company also presented results from a main study in 317 patients with diabetic macular oedema. Patients were either treated with Macugen or given a 'sham' injection, in which a syringe is pressed against the eye with nothing actually injected. The main measure of effectiveness was the number of patients after one year who could read 10 more letters than they previously could in a standard eye test. The patients were tested again at the end of the second year.

The application was withdrawn after 'day 90'. This means that the CHMP had evaluated the initial documentation provided by the company and formulated lists of questions. The CHMP was assessing the company's responses to the questions at the time of the withdrawal.

Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had concerns mainly about the effect of the treatment. The CHMP's main concern was that the effect of Macugen in the main study was not convincing, in particular the results at the end of the second year where Macugen was not proven to be more effective than the sham injection. The improvements seen at the end of the first year were not maintained. Therefore, at the time of the withdrawal, the CHMP was not fully convinced that the benefits of Macugen outweigh its risks in patients with visual impairment due to diabetic macular oedema.

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

The company informed the CHMP that, as at the time of the withdrawal, there were no consequences for patients currently included in clinical trials using Macugen. If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.

There are no consequences on the use of Macugen in its authorised indication.

Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Macugen (pegaptanib)

Reference Number: EMA/CHMP/563649/2011

English (EN) (65.01 KB - PDF)

First published: 27/07/2011Last updated: 27/07/2011
View

Key facts

Name of medicine
Macugen
EMA product number
EMEA/H/C/000620
Active substance
pegaptanib
International non-proprietary name (INN) or common name
pegaptanib
Therapeutic area (MeSH)
Wet Macular Degeneration
Anatomical therapeutical chemical (ATC) code
S01LA03
Marketing authorisation holder
PharmaSwiss Ceska Republika s.r.o
Date of issue of marketing authorisation valid throughout the European Union
31/01/2006
Date of withdrawal
15/07/2011

Documents

Withdrawal assessment report for Macugen

AdoptedReference Number: EMA/737688/2011

English (EN) (2.97 MB - PDF)

First published: 29/09/2011Last updated: 29/09/2011
View

Macugen: Withdrawal letter

English (EN) (139.87 KB - PDF)

First published: 27/07/2011Last updated: 27/07/2011
View

Pfizer Limited withdraws its application for an extension of the indication for Macugen (pegaptanib sodium)

Reference Number: EMA/567717/2011

English (EN) (95.36 KB - PDF)

First published: 19/07/2011Last updated: 19/07/2011
View

Related information on withdrawals

The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, and includes a link to the company's formal withdrawal letter.

An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

More information on Macugen

  • Macugen
This page was last updated on 27/07/2011

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