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Manufacturing hitches cited for Lilly/BI drug rejection

Published on 06/03/14 at 09:03am
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The FDA has refused to approve a new diabetes treatment from Lilly and its partner Boehringer Ingelheim due to ongoing manufacturing problems at the latter’s site in Germany.

The plant which is at Boehringer’s Rhein facility, was inspected by the US regulator in 2012 and the firm was later warned of a number of faults.

Among the violations uncovered during the inspection was a failure to investigate contamination of APIs with foreign particles, with batches of API subsequently passed and used in the manufacture of finished products.

The drug in question is empagliflozin which will not need new clinical trial data, the two companies confirmed in a statement. They will however, need to fix the problems at the German plant before the treatment has a chance of approval.

Empagliflozin is part of a class of a new class of SGLT2 inhibitors that includes Johnson & Johnson’s Invokana (canagliflozin) and AstraZeneca’s Forxiga (dapagliflozin).

They all work in similar ways, namely by helping the body get rid of sugar through the kidneys, rather than having it sit within the circulatory system – something that can cause damage to patients’ arteries.

The FDA re-inspection of Boehringer’s plant is continuing, said Emily Baier, a spokeswoman for the company. “The inspection is reviewing aspects related to production, processes, quality assurance and other related