Sanofi-Aventis gets US OK for disposable insulin pen
needle and syringe method of administering insulin, now that the
Food and Drug Administration (FDA) has granted marketing approval
to Sanofi-Aventis' Lantus SoloStar.
The prefilled, disposable insulin pen incorporates the French company's 24-hour basal insulin Lantus (insulin glargine). Indicated for the treatment of hyperglycaemia in people with type 1 or type 2 diabetes, Lantus SoloStar is expected to be available in US pharmacies later this year. It is the only disposable insulin pen that allows patients to administer insulin doses ranging from one to 80 units in a single injection, Sanofi-Aventis notes. The product made its worldwide debut in Germany on 2 April. SoloStar pens for administering Lantus and Sanofi-Aventis' fast-acting prandial insulin Apidra (insulin glulisine) were approved by the European Commission in September 2006. Further European launches of Lantus SoloStar are planned over the next year and Apidra SoloStar will follow as a "second step", Sanofi-Aventis said. Apidra has also been filed for approval in the US, where the FDA's review is "ongoing", the company added. The US is still a relatively unsatisfied market for insulin pens. While pens now account for some 56 per cent of all insulin units delivered worldwide, with a volume share of 94 per cent in Japan and 86 per cent in Europe, they make up only about 14 per cent of all units delivered in the US. Within that relatively small segment, however, disposable pens have the monopoly with a volume share of roughly 73 per cent, while in Europe they account for just 46 per cent of all pen deliveries. Sanofi-Aventis will be hoping it can change the habits of US diabetics with a product that accentuates convenience and ease of use, both in terms of its insulin formulation and the associated delivery technology. The number one prescribed insulin worldwide, Lantus is the only 24-hour formulation approved exclusively for injection once a day, the company points out. While most insulins have a 'peak of action', with Lantus the drug is released into the bloodstream at a relatively constant rate throughout the day and night. Sanofi-Aventis has also designed the SoloStar pen to address a broader spectrum of patient needs than currently available injection devices, such as Eli Lilly's Humulin/Humalog pen and Novo Nordisk's FlexPen. In particular, it is highlighting the efficiency of SoloStar's drive mechanism, which in comparative tests reduced the necessary injection force by anything from 30 per cent to 50 per cent against FlexPen and the Humulin/Humalog pen. This is an important consideration given that up to 58 per cent of people with diabetes have limited joint mobility of the hand and significantly weakened grip strength, often as a result of connective tissue disorders or diabetic neuropathy, Sanofi-Aventis says. Results from laboratory testing of Lantus SoloStar, published in the March issue of Expert Opinion of Drug Delivery, further demonstrated that the pen accurately and consistently delivered the dialled dose of insulin well within the International Organization for Standardization (ISO) test standard, the company noted.