Issarlos
Application withdrawn
The application for this medicine has been withdrawn
MedicineHumanApplication withdrawn
- Application under evaluation
- Withdrawal of application
Overview
On 17 March 2014, Les Laboratoires Servier officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its applications for marketing authorisation of Ditelos and Issarlos for the treatment of osteoporosis.
Ditelos and Issarlos are identical medicines that contain the active substances strontium ranelate and cholecalciferol. They were to be available as sachets containing strontium ranelate (2 g) and cholecalciferol (1000 international units) as granules to be made up into a suspension to be taken by mouth.
Ditelos/Issarlos was expected to be used to treat severe osteoporosis (a disease that makes bones fragile) in postmenopausal women and men who are at risk of not getting enough vitamin D and have an increased risk of fractures (broken bones).
Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down. Gradually, the bones become thin and fragile, and more likely to break. Strontium ranelate, one of the active substances in Ditelos/Issarlos, stimulates bone formation and reduces bone breakdown. Cholecalciferol is a form of vitamin D which is essential for bone development and health.
The applicant presented data from one main study involving 518 patients with osteoporosis and with low levels of vitamin D. In this study, patients were given either strontium ranelate with cholecalciferol or strontium ranelate alone for 6 months. The main measure of effectiveness was the restoration of vitamin D levels.
The applications were withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions. After the CHMP had assessed the company's responses to the last round of questions, there were still some unresolved issues.
Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had had some concerns and was of the provisional opinion that Ditelos/Issarlos could not have been approved for the treatment of osteoporosis. The CHMP noted that the company had not submitted all the required documentation relating to the manufacture of the medicine. Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the applications for Ditelos/Issarlos.
In its letter notifying the Agency of the withdrawal of the applications, the company stated that the withdrawal was due to not being able to gather sufficient data, within the available timeframe, on the pharmaceutical aspects of the medicine.
The company informed the CHMP that there are currently no ongoing clinical trials or compassionate use programmes for Ditelos/Issarlos.
Key facts
- Name of medicine
- Issarlos
- Active substance
- strontium ranelate
- colecalciferol
- Anatomical therapeutic chemical (ATC) code
- M05BX
- EMA product number
- EMEA/H/C/002756
- Marketing authorisation applicant
- Les Laboratoires Servier
- Withdrawal of application
- 17/03/2014
News on Issarlos
This page was last updated on