EC approves marketing authorisation for insulin degludec

Source: PharmaTimes Area: News According to a report by PharmaTimes, the European Commission (EC) has approved marketing authorisation for insulin degludec (Tresiba) and insulin-degludec in combination with insulin aspart (Ryzodeq).   Insulin degludec binds specifically to the human insulin receptor and results in the same pharmacological effects as human insulin. The manufacturer claims that insulin degludec is associated with a lower risk of nocturnal hypoglycaemia when compared with insulin glargine. However, despite positive effects on nocturnal hypoglycaemia overall hypoglycaemia remained the most common side effect.   Novo expects to launch Tresiba in the UK during the first half of 2013 and in other European markets thereafter. Ryzodeg is currently scheduled to be launched next year.   The approving panel has also unanimously recommended that a cardiovascular outcomes trial should be conducted, but said this could be done post-approval.
Source: NeLM - News - Category: Drugs & Pharmacology Source Type: news