FDA accepts for review Ironwood and Allergan's sNDA for 72 mcg linaclotide in CIC
The FDA Prescription Drug User Fee Act target action date is expected to occur in early 2017.
Ironwood Pharmaceuticals and Allergan have announced that the FDA has accepted for review the supplemental New Drug Application (sNDA) for the 72 mcg dose of linaclotide for use in the treatment of adults with chronic idiopathic constipation (CIC). The sNDA for the 72 mcg dose of linaclotide is based on efficacy and safety data from a double-blind, placebo-controlled Phase III clinical trial of 1,223 adult patients with CIC. The FDA Prescription Drug User Fee Act (PDUFA) target action date is expected to occur in early 2017.
If approved by the FDA, the 72 mcg dose of linaclotide would provide an additional treatment option for adult patients with CIC. Linaclotide is currently approved by the FDA for the treatment of adults with CIC as a 145 mcg capsule to be taken once per day. In addition, it is approved for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) as a 290 mcg capsule to be taken once per day. Since FDA approval in December of 2012, more than 1 million unique patients have filled a prescription for linaclotide, according to IMS Health.
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