EU smiles on Lilly and Boehringer's FDA-rejected diabetes drug

European regulators are recommending approval for Boehringer Ingelheim and Eli Lilly's ($LLY) latest diabetes offering, shrugging off a manufacturing issue that spiked the drug's FDA approval and putting the pair in line for third place in a new class of treatments.

The European Union's Committee for Medicinal Products for Human Use (CHMP) has voted in favor of empagliflozin, a Type 2 diabetes drug that blocks SGLT2 proteins and thus spurs the body to ditch excess sugars through the urine. Final say now falls on the European Commission, which generally follows CHMP's recommendations and weighs in within two months, and Boehringer and Lilly plan to market the drug as Jardiance if and when it wins approval.

Meanwhile, the duo is still smarting over the FDA's rejection of empagliflozin earlier this month. The agency took no issue with the drug's safety or efficacy profile, the companies said, but instead cited manufacturing issues at the Boehringer plant where it would be produced, holding off approval until the German drugmaker took care of some "previously observed deficiencies." Neither firm has laid out a timeline for a resubmission.

In a summary of opinion released Friday, the CHMP made no mention of any manufacturing concerns, instead cheering empagliflozin's risk-benefit profile while noting its ties to an increase in genital and urinary tract infections, common among drugs in its class.

But while the EU nod lines Boehringer and Lilly up for an EU debut, they'll have contend with an already crowded market for SGLT2-targeting treatments. Johnson & Johnson ($JNJ) is already on the U.S. and European markets with its first-moving Invokana (canagliflozin), and AstraZeneca ($AZN) finally picked up FDA approval for its long-delayed Farxiga (dapagliflozin) in January. Analysts figure the market for SGLT2 blockers could peak at close to $2 billion, but just how much of that haul will fall to Boehringer and Lilly remains to be seen.

If everything works out for empagliflozin, it'll be the third European approval for the pair's 4-year-old diabetes alliance, the companies note.

- read the statement
- here's CHMP's summary (PDF)

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