Manufacturing hitches cited for Lilly/BI drug rejection
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.
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 areas,” she told Bloomberg.
But it could take a further six months after the inspection for the FDA to decide whether the problems have been fixed.
Alex Arfaei, an analyst with BMO Capital Markets, said despite the setbacks he still expects the FDA to approve empagliflozin this year, and for it to generate eventual annual collaboration revenue of $1.6 billion for Lilly.
Boehringer has been wrestling with other quality issues in its manufacturing network, but these have focussed mainly in its US contract manufacturing subsidiary Ben Venue Laboratories, which was forced to stop production at its plant in Bedford, Ohio, in November 2011 and is currently operating under a consent decree with the FDA.