The CHMP agenda for this week’s meeting (October 14-17) has been released, and it includes two notable items (Lilly nasal glucagon opinion and Toujeo age indication extension). Below, FENIX provides diabetes-related highlights and insights from the CHMP agenda.
Zealand Pharma announced positive topline results from its pediatric dasiglucagon hypoglycemia rescue trial in pediatric patients from 6 to 17 years of age. Below, FENIX provides insights on dasiglucagon in the context of the recent Lilly Baqsimi (nasal glucagon) and Xeris (subcutaneous Gvoke) FDA approvals.
Xeris Pharmaceuticals announced FDA approval of its Gvoke pre-filled syringe (PFS) and auto-injector for hypoglycemia rescue in patients 2 years of age and older. Xeris held an associated call with investors following the approval announcement. The approval comes exactly 3-months after the PDUFA delay imposed by FDA. Below, FENIX provides an in-depth Gvoke label analysis in the context of the recent approval of Lilly’s nasal glucagon, Baqsimi.
Zealand hosted its Q2 ’19 earnings call and provided updates to its clinical and commercial activities. Of note, Zealand has begun ramping up US operations with the intention to commercialize the dasiglucagon HypoPal without a partner. Below, FENIX provides highlights and insights from the call.
Yesterday, Xeris published its Q2 ’19 earnings press release highlighting the September 10, 2019 PDUFA for its hypoglycemia rescue product ‘Gvoke.’ Gvoke launch is anticipated in Q4 ’19. Furthermore, the company disclosed utilizing the additional data from the fourth Ph3 trial to file an MAA to EMA by YE 2019. Below, FENIX provides additional thoughts on Gvoke in the context of its additional Ph3 data, and other novel glucagon rescue products.
Lilly hosted its Q2 ’19 earnings call and provided updates across its diabetes business. Of note, Lilly’s pipeline now lists empa T1DM as being filed (FDA refused to accept the initial sNDA). Following the 36-week results from Lilly’s AWARD-11 study, Lilly said it plans to file high-dose Trulicity with regulatory authorities “by late 2019.” Furthermore, Lilly’s oral GLP-1RA, called “GLP-1 NPA” (GLP-1 non-peptide agonist), has advanced to Ph1. Below, FENIX provides diabetes-related highlights and insights from the call, including the assumption that the REWIND CHMP agenda listing for July was only for adoption of supplementary information.
Recently, Lilly’s novel nasal glucagon hypo rescue product, Baqsimi [BAK-see-mee], was approved by FDA. Below, FENIX provides an in-depth analysis of the Baqsimi label, pricing strategy, and potential market implications for other novel glucagon rescue products from Xeris, Zealand, and Mylan.
Lilly’s nasal glucagon has been approved by FDA under the brand name “BAQSIMI”. Recall, during Lilly’s Q1 ’19 earnings call, Lilly announced that FDA delayed the approval by 3 months. FENIX will be conducting an in-depth label analysis in the coming days.
The CHMP agenda for this week’s meeting has been released, and it includes eight notable items of which Lilly’s REWIND is likely the most significant. Below, FENIX provides diabetes-related highlights and insights from the CHMP agenda.
Xeris Pharmaceuticals announced the first patient has been dosed in the Ph2 trial evaluating its ready to use glucagon in patients who experience hypoglycemia after undergoing bariatric surgery (PBH). Xeris previously discussed intentions to initiate this Ph2 trial in a press release from December 2018. Curiously, neither of the press releases nor the CT.gov record makes any reference to delivery via the Insulet Omnipod which had been used in previous Xeris clinical trials with published clinical results. Below, FENIX provides insight into potential reasons why this trial is not using Omnipod.