Thanks for the DD. Alfasigma USA Acquires ZELNOR
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Posted On: 09/01/2019 5:27:53 PM
Thanks for the DD.
Alfasigma USA Acquires ZELNORM™ (tegaserod) for Reintroduction to the US Market•Alfasigma USA has acquired the brand ZELNORM (tegaserod), a treatment for IBS-C, from Sloan Pharma S.à r.l.
•In early 2019, ZELNORM was approved for reintroduction by the FDA for the treatment of adult women less than 65 years of age with IBS-C.
•Alfasigma USA plans to relaunch the brand in the United States, making ZELNORM available by prescription in the coming weeks
An analysis of data collected on over 18,000 patients demonstrated adverse cardiovascular events in 13 of 11,614 patients treated with Zelnorm (a rate of 0.11%) as compared with 1 of 7,031 patients treated with placebo (a rate of 0.01%). Novartis alleges all of the affected patients had preexisting cardiovascular disease or risk factors for such, and further alleges that no causal relationship between tegaserod use and cardiovascular events has been demonstrated.
Yes a voluntary withdrawal. Zelnorm (tegaserod) is for folks who have not responded well to other treatments. Sounds like an astute purchase of a shelved drug. AS is hedging their future as IBD keeps growing worse by the year. B with it's anti-inflammatory healing properties could very well take the market away from IBD Biologics
Alfasigma USA Acquires ZELNORM™ (tegaserod) for Reintroduction to the US Market•Alfasigma USA has acquired the brand ZELNORM (tegaserod), a treatment for IBS-C, from Sloan Pharma S.à r.l.
•In early 2019, ZELNORM was approved for reintroduction by the FDA for the treatment of adult women less than 65 years of age with IBS-C.
•Alfasigma USA plans to relaunch the brand in the United States, making ZELNORM available by prescription in the coming weeks
An analysis of data collected on over 18,000 patients demonstrated adverse cardiovascular events in 13 of 11,614 patients treated with Zelnorm (a rate of 0.11%) as compared with 1 of 7,031 patients treated with placebo (a rate of 0.01%). Novartis alleges all of the affected patients had preexisting cardiovascular disease or risk factors for such, and further alleges that no causal relationship between tegaserod use and cardiovascular events has been demonstrated.
Yes a voluntary withdrawal. Zelnorm (tegaserod) is for folks who have not responded well to other treatments. Sounds like an astute purchase of a shelved drug. AS is hedging their future as IBD keeps growing worse by the year. B with it's anti-inflammatory healing properties could very well take the market away from IBD Biologics
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