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news.The FDA has approved Teva Pharmaceutical's Azilect for the treatment of early Parkinson's disease patients, and in conjunction with levodopa for the moderate-to-advanced stages of the disease.
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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 alliance between the two companies.
Approval for Azilect was based on data from three large, multinational, placebo-controlled clinical studies in over 1,600 patients which showed the drug to be effective, and well tolerated.
“Azilect fills an important unmet need, offering a new treatment which uniquely combines efficacy, convenient once-daily dosing and good tolerability,” commented Israel Makov, president and CEO of Teva.
Eisai, which has been involved in the development of the drug since May 2003, will continue to collaborate with Teva on the global co-development of the drug for a potential use in the treatment of Alzheimer’s disease. However, Teva said that Eisai is still considering whether or not to co-promote the drug for Parkinson’s disease in US.