Teva's Azilect approved for early PD in Canada

Israel's Teva Pharmaceutical Industries says that Azilect (rasagiline tablets), the first once-daily oral treatment for Parkinson's disease, has just been approved by Health Canada. The drug is cleared for use as monotherapy in early PD and as adjunct therapy to levodopa in moderate-to-advanced cases of the neurodegenerative disorder and is expected to become available in Canada later this month. Depite the positive news, on the day of the announcement, August 21, shares in the Israeli drugmaker fell $0.13 to $34.21 on the Nasdaq.

PD is estimated to affect some 4 million people worldwide, of which approximately 100,000 are in Canada. In 2005, global sales of PD drugs reached about $3.0 billion, Teva noted, adding that, earlier this year, Azilect was approved for the same indications in the USA (Marketletter May 29).

The approval of the agent, which was developed as part of a long-term co-development and European marketing alliance with Copenhagen, Denmark-based drugmaker H Lundbeck AS, was based on data from three large, multicenter, multinational, double-blind, randomized, placebo-controlled clinical studies in over 1,500 patients.