Sanofi's Wayrilz Gets Orphan Drug Tag for IgG4-Related Disease in Japan [Yahoo! Finance]
Sanofi - American Depositary Shares (SNY)
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Source: Yahoo! Finance
Sanofi SNY announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has granted orphan drug designation to Waylirz (rilzabrutinib) for the treatment of IgG4-related disease (IgG4-RD). The drug is not yet approved for this indication in any market. How Does the Orphan Tag Benefit Sanofi's Drug Development? Orphan drug designation is granted by the MHLW to therapies intended for the treatment of rare diseases or conditions affecting fewer than 50,000 people in Japan. The goal is to encourage drug development for rare diseases or conditions by offering incentives such as priority consultation and guidance, preferential tax treatment, subsidies and priority review. For Sanofi, this designation provides Waylirz with important regulatory and financial advantages as it advances through clinical development for IgG4-RD, a rare disease affecting nearly any organ and may lead to progressive organ damage if left untreated. The orphan drug designation may help accelerate progre
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