Ironwood’s Phase III Data Could Expand Linzess Market Share
The company also hopes that positive safety data for pediatric patients could help with discussions with the FDA to make an OTC version of the drug.
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Ironwood presented Phase III data on Linzess (linaclotide) at Digestive Disease Week for the treatment of 6-17 year-olds with functional constipation; US FDA approval is expected in a month.
Teva will pay out more than $1m as part of a settlement deal over Intuniv (guanfacine) involving indirect purchasers, newly-filed court documents reveal. Meanwhile, the firm has also just gained a 2029 entry date for a 72mcg strength of its linaclotide rival to Linzess through a separate settlement.
The company has no development programs left in its R&D pipeline and will focus entirely on the commercialization of IBS drug Linzess while seeking late-stage assets from external sources.