Tag Archives: stable glucagon

Xeris Glucagon Approved by FDA; Investors Appear Unimpressed

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.

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FENIX Analysis: Baqsimi, Lilly’s Novel Nasal Glucagon Hypo Rescue Product

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.

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Lilly Nasal Glucagon Approved As “BAQSIMI”

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.

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Xeris Glucagon Filing Accepted by FDA; June 10, 2019 PDUFA

Xeris Pharmaceuticals announced FDA has accepted the NDA filing for its stable glucagon with a PDUFA date on Monday, June 10, 2019, the Monday of ADA. This confirms FENIX’s previous belief that Xeris’s stable glucagon would have a 10-month review period. Below, FENIX provides thoughts on Xeris’s later-than-anticipated regulatory submission and impending market dynamics in the glucagon rescue market.

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