FDA-nixed diabetes drug from Lilly, Boehringer could face rough path to stardom

The FDA may not have been so keen on Boehringer Ingelheim and Eli Lilly's ($LLY) Type 2 diabetes drug Jardiance when it issued a complete response letter in March for problems at its future production site. That didn't stop its across-the-pond counterpart from green-lighting the drug Friday--and it won't keep it from cracking the blockbuster barrier, analysts say. But that doesn't mean getting there will be easy.

After March's positive recommendation from the EU's Committee for Medicinal Products for Human Use (CHMP), the European Commission (EC) has given Jardiance the thumbs up. The once-daily tablet, a member of the up-and-coming SGLT2 class, can be used for patients who are intolerant to metformin or alongside other glucose-lowering meds like insulin.

BI CMO Klaus Dugi

"In Europe, the number of people with type 2 diabetes is growing and management of the condition increasingly requires a holistic approach for individuals and their needs," Boehringer's chief medical officer, Klaus Dugi, said in a statement. "We aim to bring the very latest therapy options to people living with Type 2 diabetes and are delighted empagliflozin will become available in Europe."

It's the third European approval for the BI/Lilly tandem, which formed in 2011. It's also the third in its class--which works by helping remove excess glucose from the body through urine--to gain access to the European market, following AstraZeneca's ($AZN) Forxiga and Johnson & Johnson's ($JNJ) Invokana.

While ISI analysts told FiercePharma they expect Jardiance to rack up worldwide sales of about $2 billion--with Boehringer and Lilly each netting about half of that--it won't necessarily be a cruise to blockbuster land. The SGLT2 trio is up against some serious diabetes heavyweights, like Sanofi's ($SNY) $7-billion-plus behemoth Lantus and Merck's ($MRK) Januvia.

Both Invokana and Forxiga have already faced safety worries over the risk of genital and urinary tract infections, and cost-effectiveness gatekeepers in the U.K. and Germany have taken issue with Forxiga, too, saying they weren't convinced it works any better than competitors already in use.

And that's not to mention the manufacturing struggles that have already complicated Jardiance's approval pathway with the FDA, which said a couple months back that Boehringer needed to fix "deficiencies" at one if its facilities. Since then, the companies haven't issued an update on the matter; Lilly told FierceBiotech in an email Friday only that they plan to submit their response to the agency "as soon as possible."

- read the release
- see FierceBiotech's take

Special Reports: 10 Top-selling Diabetes Drugs - 2012 | The top 10 pharma companies by 2013 revenue - Eli Lilly

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