Vitragan
Application withdrawn
The application for this medicine has been withdrawn
MedicineHumanApplication withdrawn
- Application under evaluation
- Withdrawal of application
Overview
On 25 April 2007, ISTA Pharma Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Vitragan, for the treatment of vitreous haemorrhage.
Vitragan is a powder containing the active substance hyaluronidase (ovine). It was to be made up into a solution for injection into the eye.
Vitragan was expected to be used to treat vitreous haemorrhage (bleeding into the vitreous humour, the jelly-like fluid in the central chamber of the eye) in adults. This was intended to improve vision and to help doctors in their diagnosis of underlying problems in the retina (the light-sensitive surface at the back of the eye).
The active substance in Vitragan, hyaluronidase (ovine), is an enzyme extracted from sheep. It is expected to work by breaking down a molecule in the vitreous humour called hyaluronic acid. When the acid is broken down, the vitreous humour turns from a jelly into a liquid, allowing cells to move more freely through the vitreous humour. This was expected to allow phagocytes (specialised 'scavenger' cells of the immune system) to clear away any blood clots from the vitreous humour.
The effects of Vitragan were first tested in experimental models before being studied in humans. The company also presented the results of two main studies involving 1,306 patients with vitreous haemorrhage, where the effects of a single injection of Vitragan were compared with those of placebo (a dummy treatment). The main measure of effectiveness was the improvement in vision three months after the injection, assessed using a standard letter chart.
The application was at day 180 when the company withdrew. After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding. The CHMP normally takes up to 210 days to evaluate a new application. Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company. Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180. Following the CHMP's opinion, it usually takes around 2 months for the European Commission to grant a licence.
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 some concerns and was of the provisional opinion that Vitragan could not have been approved for the treatment of vitreous haemorrhage.
The CHMP had concerns over the benefits of Vitragan, since the main studies had not shown convincingly that it was more effective than available options for managing vitreous haemorrhage. The Committee was also concerned over the safety of the medicine and the consistency of the medicine between batches.
Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Vitragan had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
The letter from the company notifying the EMEA of the withdrawal of the application is available under the tab 'All documents'.
The company informed the CHMP that there are currently no clinical trials or compassionate use programmes with Vitragan.
Key facts
- Name of medicine
- Vitragan
- Therapeutic area (MeSH)
- Vitreous Hemorrhage
- EMA product number
- EMEA/H/C/000696
- Marketing authorisation applicant
- ISTA Pharma Limited
- Withdrawal of application
- 25/04/2007
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