AstraZeneca announced the European Commission (EC) approved Forxiga in T1DM. The news follows the positive CHMP opinion on February 1, 2019. Recall, Lexicon/Sanofi’s sotagliflozin also received a positive CHMP opinion on March 1, 2019 followed by a CRL from FDA on March 22, 2019. Below, FENIX provides thoughts on the Forxiga EU approval and readthrough to sotagliflozin and Jardiance.

Sanofi and Lexicon announced that FDA issued a CRL for the sotagliflozin T1DM review. Lexicon subsequently hosted a call with investors but did not provide any additional insight into the content of the CRL letter. Below, FENIX provides thoughts on the sota T1DM CRL and impact to the T1DM market including a winners & losers analysis.

Lexicon hosted its Q4 ’18 earnings call and provided brief updates to its Zynquista (sotagliflozin) clinical and regulatory activities across T1DM and T2DM. With the impending March 22, 2019 sota T1DM PDUFA, Lexicon senior management were reluctant to make comments or answer questions on the topic. For the sota T2DM development program, Lexicon said topline Ph3 data will start reading out in Q2 ’19. Below, FENIX provides highlights and insights from the call.

CHMP has adopted a positive opinion for the use of 200 and 400mg Zynquista (sotagliflozin) in T1DM.  Recall, on January 31, CHMP adopted a positive opinion for the use of Forxiga in T1DM (previous FENIX insight). Of note, the proposed limitations for use of both Zynquista and Forxiga are identical. Below, FENIX provides insights from the Zynquista positive CHMP opinion and potential read-through to the upcoming Zynquista FDA action date.

Earlier this week, FDA tentatively approved Teva’s generic version of Farxiga. Below, FENIX provides evidence suggesting Teva filed its generic dapa via Paragraph III as well as thoughts on potential generic dapa launch timings, particularly Zydus.