– Newly published data highlights additional efficacy endpoints from trial –
– Linaclotide is the first and only FDA-approved prescription therapy for children and adolescents aged 6-17 years.
– LINZESS is the first and only FDA-approved prescription therapy for functional constipation in this patient population –
– Approval brings a much-needed option to an estimated 6. | June 12, 2023
Ironwood Pharma (IRWD) Announces FDA Approval of New Indication for LINZESS for Functional Constipation in Pediatric Patients Ages 6-17 Years-Old streetinsider.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from streetinsider.com Daily Mail and Mail on Sunday newspapers.
– Pivotal Phase III data will be spotlighted via an oral presentation –
– Additional efficacy and safety data will be featured across four posters –
. | June 18, 2023
/PRNewswire/ AbbVie (NYSE: ABBV) today announced that it has submitted a supplemental New Drug Application (sNDA) for linaclotide (LINZESS®) to the U.S..