The FDA has four target action dates this week, including approvals for drugs to treat functional constipation, Alagille syndrome, myelofibrosis and symptomatic obstructive hypertrophic cardiomyopathy. Ironwood Pharmaceuticals' Linzess is set to be approved as a treatment for functional constipation in children aged 6-17 years on June 14th. Albireo's Bylvay may also receive approval on June 15th to add the rare genetic disease Alagille syndrome to its label. Bristol Myers Squibb's Camzyos could lower the need for septal reduction therapy in patients with symptomatic obstructive hypertrophic cardiomyopathy if it receives approval on June 16th. GSK's momelotinib could also be approved by the same date as a treatment for myelofibrosis patients with anemia.
Ironwood Pharmaceuticals’ supplemental New Drug Application (sNDA) for Linzess to treat functional constipation in kids and teens aged 6–17 years is set to be released on June 14th. Albireo's sNDA seeking to add the rare genetic disease Alagille syndrome to Bylvay’s label will have its verdict announced on June 15th. Bristol Myers Squib