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First generic Lovenox approved in US

The US Food and Drug Administration has approved for marketing the first generic version of sanofi-aventis' blockbuster blood-thinner Lovenox

The US Food and Drug Administration (FDA) has approved for marketing the first generic version of sanofi-aventis' (S-A) blockbuster blood-thinner Lovenox (enoxaparin sodium injection). It is indicated for a number of uses, including prevention of deep vein thrombosis (DVT).

The FDA has approved an abbreviated new drug application (ANDA) jointly submitted by Sandoz and Momenta Pharmaceuticals. The approval was granted in spite of the objections of S-A, which has been engaged in a years-long battle to keep generic versions of Lovenox from winning approval.

Aventis filed a citizen petition in 2003, before its merger with Sanofi, requesting that the FDA withhold approval unless the ANDA sponsors conducted their own clinical studies – an obligation not generally required for the approval of generic drugs. The company then followed up with four different supplements over a four-year period and with eight sets of comments regarding the petition, the last of which was filed last year.

Lovenox, which has been sold in the US since 1993, is a low molecular weight heparin (LMWH) whose active ingredient is a naturally-derived complex mixture of sugar molecules. This made the requirement that the generic drugmaker prove that its product contains the same active ingredient as the brand name drug more complex than usual, the FDA explained.

Applications for approval of generic enoxaparin were submitted to the FDA in the early 2000s, but the agency took years to determine the appropriate way to evaluate them.

The FDA explained: "Approval of generic enoxaparin has involved a variety of challenges, including determining whether the FDA could accept an application for generic enoxaparin, given its complex chemical structure; demonstrating 'sameness' to the brand name product and its likelihood of producing immunogenic reactions; (and) addressing the potential for contamination of heparin, from which LMWH, such as enoxaparin, is produced."

However, FDA scientists were able to formulate a scientific approach for demonstrating active ingredient sameness for the complex product, the agency said. The approach is made up of five criteria relating to the physical and chemical characteristics of enoxaparin, the nature of the heparin material and the chemical process used to break up heparin chains into smaller pieces, the nature and arrangement of components that constitute enoxaparin, laboratory measurements of the product's anticoagulant activity, and certain aspects of the drug's effect in humans.

S-A said it "is considering all appropriate legal options" in response to the FDA approval.

In addition, the company said it would fight the generic version in the marketplace by "making healthcare professionals aware of the complexities related to the biologic composition and manufacturing of low molecular weight heparins and Lovenox, so that they can make informed decisions about the best treatment option for their patients."

However, S-A also took pains to stress the limited effect that the generic competition to Lovenox would have on its bottom line, noting that the US generic would compete with less than 60 per cent of overall global sales of the branded drug.

27th July 2010

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