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FDA approves Teva's Azilect for parkinson's disease
Jerusalem, Israel | Thursday, May 18, 2006, 08:00 Hrs  [IST]

The US FDA has approved Teva Pharmaceutical's Azilect (rasagiline tablets) as a treatment for Parkinson's disease both as initial monotherapy in early Parkinson's disease patients and as adjunct therapy to levodopa in moderate-to-advanced stages of the disease. Azilect, developed by Teva based on research originating from the Technion Israel Institute of Technology, will become available in the US within 8 to 10 weeks.

Israel Makov, president and CEO of Teva commented, "We are extremely pleased to receive FDA approval for Azilect, the only once-daily product and one of the few treatment options in the US indicated for all stages of parkinson's disease including as monotherapy in the early stages and as adjunct to levodopa in the more advanced stages. Azilect fills an important unmet need, offering a new treatment which uniquely combines efficacy, convenient once-daily dosing and good tolerability."

Makov went on to say: "We have recently embarked on a large clinical study (ADAGIO), to investigate the impact of Azilect on slowing the progression of parkinson's disease. If it is demonstrated that Azilect does indeed slow the progression of PD, this will undoubtedly represent a major breakthrough for Parkinson's disease patients."

Azilect was approved in Europe and Israel in 2005, where it has been successfully launched. In the EU, it is now marketed in 13 countries in collaboration with Lundbeck A/S as part of a long-term strategic alliance between the two companies.

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