Regulatory

FDA snubs Sanofi, Lexicon on their pitch for SGLT1/2 diabetes drug sotagliflozin, companies mum on what went wrong

Sanofi’s shot at a last-place showing for its SGLT1/SGLT2 diabetes drug has ended in a painful pratfall ahead of the finish line. The pharma giant and their partners at Lexicon $LXRX say that sotagliflozin, a major player for their diabetes portfolio, has been rejected by the FDA.

Lonnel Coats, Lexicon

Their terse release gave no explanation for what went wrong, but an expert panel provided a split vote on the money question regarding safety and efficacy, with insiders at the agency fielding big concerns about evidence of diabetic ketoacidosis.

In the US, the FDA is required to stay silent on these CRLs, leaving it up to the companies to say anything they like, or nothing at all. Lexicon is staying behind the stone wall offered by the agency.

Lexicon execs set up a quick call on Friday afternoon, but given repeated chances to characterize the issues the FDA has — and the $60 million question on whether regulators are demanding more data or posed challenges that can be dealt with in the near-term — CEO Lonnel Coats repeatedly batted back the queries without answering them.

That does not bode well for the company or any prospects it may have in the US market, as companies are routinely anxious to seize on short cuts to CRLs. Lexicon also has hundreds of millions of dollars in milestone money sitting on the table for late-stage regulatory goals and commercial launches.

Investors didn’t like the sound of silence, slamming Lexicon shares, which dropped 24%.

Eli Lilly’s Jardiance, which had an impressive followup on its cardio profile, along with J&J’s Invokana and AstraZeneca’s Farxiga are only SGLT2 targeted. Steglatro from Merck and Pfizer arrived in late 2017, leaving Sanofi and Lexicon trying to play catchup with a special 1/2 on offer for Type 1 diabetes, adding an oral drug to insulin for better glycemic control.

Every month in added delays gives the competition that much extra time to expand their leads, and challenge Sanofi and Lexicon on various unique aspects of their pitch. In the meantime, the partners expect a Q2 approval in Europe, where regulators have proven far more open to the marketing application.

While Lexicon will be punished more severely, the setback won’t play well for Sanofi, either. The company has been trying to take charge of its own destiny by pushing forward new and important drugs. But it’s been hampered by a series of snafus, including the going onbattle that it’s now fighting with officials in the Philippines over its dengue vaccine.


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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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