The US Food and Drug Administration (FDA) has approved the expansion of the indication for Teva Pharmaceutical Industries Ltd.'s/a> (NYSE: TEVA; TASE: TEVA) brand Parkinson's disease (PD) treatment Azilect (rasagiline tablets) from monotherapy and adjunct to levodopa (LD) to include adjunct to dopamine agonists (DAs). "The new indication reflects that Azilect can be used alone or in combination with other Parkinson’s disease medications. The approval reinforces the growing clinical evidence demonstrating the benefit of Azilect across all stages of PD", Teva said.
“The FDA approval of the expanded label for Azilect will be a welcome addition in the treatment of PD,” said Teva president of global R&D and chief scientific officer Michael Hayden. “Teva continues its commitment to those living with PD and to research in areas of neurodegenerative diseases to develop solutions for patients with unmet needs,” he added
Azilect is one of Teva's original drugs. Sales of Azilect totaled $371 million in 2013, 12% more than in 2012.
The FDA approval of the expanded label is based on a supplemental new drug application (sNDA) submitted by Teva, supported by data from the ANDANTE study (Add oN to Dopamine AgoNists in the TrEatment of Parkinson’s disease).The study demonstrated Azilect provides a clinical benefit by significantly improving total Unified Parkinson’s Disease Rating Scale (UPDRS) scores compared to placebo in patients on DA monotherapy, while demonstrating tolerability.
Positive results of a previous clinical trial, ADAGIO, released six years ago, have still not been translated into an expanded indication for the drug. At the time, Teva presented results indicating the possibility that the drug could actually slow the development of PD and not just treat its symptoms.
Published by Globes [online], Israel business news - www.globes-online.com - on June 9, 2014
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