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Sabril approved by FDA to treat infants

The US FDA has approved the use of Lundbeck's Sabril (vigabatrin) to treat infantile spasms

The US Food and Drug Administration (FDA) has approved the use of Sabril (vigabatrin) to treat infantile spasms. While Sabril is available in the UK and other countries, it is the first drug in the US to be approved to treat this disorder.

Sabril is an oral anti-epileptic drug developed in the US by Lundbeck, the pharmaceutical company specialising in central nervous system (CNS) disorders.

In February 2009 Lundbeck acquired the private UK-based company Ovation Pharmaceuticals with its pipeline of products, including Sabril, focused predominantly on CNS disorders. Lundbeck paid $600m immediately upon closing the acquisition of Ovation and an additional payment of $300m will be paid in connection with the FDA's approval of Sabril.

Lundbeck has, together with the FDA, established a comprehensive risk, evaluation and mitigation strategy (REMS) to manage the risk of permanent vision loss associated with the product. The Sabril REMS, which was a critical component in receiving FDA approval, specifies elements, such as restricted product distribution, required vision testing and mandatory risk-benefit assessments, to manage the risk of vision loss associated with Sabril.

Sabril was first authorised in the UK in 2001 for the treatment in combination with other anti-epileptic drugs of patients with resistant partial epilepsy with or without secondary generalisation, where all other appropriate drug combinations have proved inadequate or have not been tolerated. It was also approved as a monotherapy in the treatment of infantile spasms (West's syndrome).

The precise mechanism of Sabril's anti-seizure effect is unknown, but is believed to be the result of its action as an irreversible inhibitor of gamma-aminobutyric acid transaminase (GABA-T), the enzyme responsible for the metabolism of the inhibitory neurotransmitter GABA. This action results in increased levels of GABA in the central nervous system.

24th August 2009

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