Tag Archives: AZN

FENIX Analysis: SGLT2i HF CVOTs and Stopping Early Scenarios

Currently, there are multiple ongoing, label-enabling HF CVOTs in the SGLT2i class for Jardiance, Farxiga, and Zynquista (sotagliflozin), along with other studies exploring surrogate endpoints, biomarkers, and mechanisms of action. FENIX has created a tale-of-the-tape summary of the SGLT2i HF CVOTs along with a projected timeline for filings and launches. In summary, it is believed that AZ’s DAPA-HF CVOT has a high probability of stopping early for overwhelming efficacy and thus creating a priority review scenario to leap AZ ahead of BI/LLY by 6-12 months in this important LCM opportunity. Below is a summary of the rationale and hypothesis comparing the different development approaches by SGLT2i sponsors to improve clinical outcomes in HF patients.

This content is for Read Less members only.
Already a member? Log in here

AZ Q1 ‘18 Earnings Updates

AZ hosted their Q1 ’18 earnings call and briefly discussed their diabetes portfolio, with a particular focus on Farxiga, including H2 ‘18 readout of the DECLARE CVOT and planned H2 ’18 US filing in T1DM.

This content is for Read Less members only.
Already a member? Log in here

Bydureon Approved as Add-On to Basal Insulin

AZ has announced FDA approval of Bydureon as an add-on to basal insulin for T2DM based on the results of the DURATION-7 study. The corresponding label update may help strengthen a Bydureon message of broad use including first-injectable therapy and treatment intensification.

This content is for Read Less members only.
Already a member? Log in here

FENIX Analysis: Bydureon BCise Launch

AZ has begun actively promoting Bydureon BCise, the new autoinjector device which became available in US pharmacies in January 2018. Below, FENIX has conducted a launch analysis in the context of the broader GLP-1RA market including assessment of prescription data trends.

This content is for Read Less members only.
Already a member? Log in here

AZ’s Forxiga T1DM filed in EU

AstraZeneca recently announced the European Medicines Agency has accepted the Forxiga application for the treatment of T1DM. Of note, AZ filed with 52-week DEPICT-1 data but only 24-week data from DEPICT-2. FDA filing for Farxiga in T1DM remains projected for H2 ’18.

This content is for Read Less members only.
Already a member? Log in here

AZ Q4 ’17 Earnings Update

AZ hosted their Q4 ’17 earnings call (press release) and briefly discussed their diabetes portfolio, with a particular focus on Farxiga and Bydureon.

This content is for Read Less members only.
Already a member? Log in here

FENIX Analysis: Bydureon BCise now available

In early January AZ announced the availability of Bydureon BCise autoinjector in US pharmacies after receiving FDA approval in Oct 2017. FENIX has conducted GLP-1RA market, pricing, and co-pay card analyses.

This content is for Read Less members only.
Already a member? Log in here