Tag Archives: Farxiga

DECLARE Approval Timeline Moved Up; AZ Q2 ’19 Earnings Update

AZ hosted its Q2 ’19 earnings call and provided updates to its diabetes commercial, clinical, and regulatory activities. Importantly, AZ updated the DECLARE US/EU regulatory decision timelines which are now both anticipated in H2 ’19 (previously said to occur in 2020). AZ also disclosed it has a new Ph1 GLP-1RA compound (MEDI7219). Discussion regarding the Farxiga T1DM CRL was minimal. Below, FENIX provides diabetes-related highlights and insights from the call.

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Dapa T1DM CRL Received by AZ

Today, AZ announced it received a CRL from FDA for the Farxiga T1DM label expansion. The news comes on the heels of the July 12 NICE recommendation for Forxiga T1DM reimbursement in the UK. Below, FENIX provides thoughts on what the AZ CRL could mean for the SGLTi class in T1DM, including read-through to BI/Lilly and Lexicon/Sanofi.

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Farxiga DECLARE Positive CHMP Opinion

AstraZeneca announced it received a positive CHMP opinion for the DECLARE CVOT. AZ is anticipated to comment on the US and EU DECLARE regulatory activities during its upcoming Q2 ’19 earnings call on July 25. Below, FENIX provides brief thoughts on the impending EMA approval in the context of the ongoing FDA review.

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