New indications of TIWA Parkinson's drug aziect approved by FDA
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Last Update: 2014-06-10
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Source: Internet
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Author: User
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Source: Biovalley announced on June 9, 2014 that FDA has approved to expand the indications of azicollect (rasagiline, rasagiline) from single drug therapy and L-dopa (LD) adjuvant to dopamine agonist (DAS) adjuvant New indications indicate that zzilect can be used alone or in combination with other Parkinson's disease (PD) drugs This approval also reinforces the growing clinical evidence of aziect's therapeutic benefits across all stages of the PD population The approval of the aziect extension label is based on a supplementary new drug application (SNDA) submitted by TIWA, which is supported by data from the Andante study The anadante study was conducted in patients with Parkinson's disease who received dopamine agonist (DAS) monotherapy The data showed that aziect significantly improved the total score of Parkinson's Disease Rating Scale (UPDRS) compared with placebo, provided clinical treatment benefits for patients, and showed good tolerance.
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