The briefing documents for the June 20, 2017 LEADER adcom were posted by the FDA. Recall, Novo Nordisk submitted the sNDA efficacy supplement for Victoza (liraglutide 1.8 mg) on October 25, 2016, which suggests the PDUFA date will be on or around August 25 following a 10-month review.
Lilly hosted its Q1 ’17 earnings call and provided an update to its diabetes portfolio including pipeline and LCM activities.
Lilly has announced intentions to invest $850M in its US operations in 2017 including $85M to expand the Trulicity device assembly operations. Additionally, Lilly announced the dedication of a $140M insulin cartridge facility.
Lilly and the William Sansum Diabetes Center in Santa Barbara, California have entered into a research collaboration to further understand the unmet needs related to diabetes in the Latino population.