477 08 vildagliptin metformin (Eucreas)
SMC ISSUES ADVICE ON NEW DRUGS
The Scottish Medicines Consortium (SMC) today (Monday) accepted the following drug following an an abbreviated submission (the abbreviated submissions process is used for new formulations at same or lesser cost, and new tablet strength or size):
- vildagliptin 50mg/metformin hydrochloride 850mg film coated tablets and vildagliptin 50mg/metformin hydrochloride 1000mg film coated tablets (Eucreas 50mg/850mg and 50mg/1000mg) for the treatment of type 2 diabetes mellitus patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets.
Notes for editors – Glossary:
- Type 2 diabetes mellitus - A long-term condition where the body is unable to regulate the amount of glucose in the blood properly. Diabetes develops when the body no longer responds adequately to the natural hormone insulin, or when production of insulin is too low.
Notes for editors – About SMC:
1. The SMC advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) in Scotland about the use of all newly licensed medicines, all new formulations of existing medicines and any major new indications for established products. It does this after new medicines have been licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) / European Medicines Evaluation Agency (EMEA).
2. The SMC process encourages pharmaceutical manufacturers to make a submission before a product is launched. The aim is to issue advice as soon as possible after the launch of a product.
3. Membership of the SMC has been derived from NHS Boards across Scotland. Membership is wide ranging across multi-disciplines of NHS Scotland and also includes members of the Association of British Pharmaceutical Industry (ABPI), and patient and voluntary group representatives.
4. This advice represents the views of the Scottish Medicines Consortium and was arrived at after careful consideration of the available evidence. Health professionals are expected to take due account of this recommendation when exercising their clinical judgement. This recommendation does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
For further information, contact Stephen Ferguson on 07779 329 689 or Colin McAllister on 07813 095930