FDA panel votes against Lilly’s EPI treatment
INDIANAPOLIS — An advisory committee of the Food and Drug Administration voted last week not to recommend approval of a drug from Eli Lilly.
The FDA Gastrointestinal Drugs Advisory Committee said it recommended that additional studies be conducted prior to the FDA’s review of liprotamase, a nonporcine pancreatic enzyme replacement therapy, for the treatment of exocrine pancreatic insufficiency. EPI is a disease resulting from cystic fibrosis, removal of the pancreas, chronic pancreatitis and other conditions.
Lilly’s PERT was developed by Alnara, which the drug maker acquired in July 2010.
The FDA is not required to follow the recommendation of its advisory committees.
Roche’s CFO to retire
BASEL, Switzerland — Roche CFO Erich Hunziker will retire from the company at the end of March, the Swiss drug maker said Monday.
Hunziker was appointed CFO and a member of the corporate executive committee in 2001, and last year took on the additional role of chief information officer.
Alan Hippe, a former executive from German tire maker Continental and manufacturer ThyssenKrupp, will replace Hunziker as CFO.
Cumberland gets FDA OK for Acetadote formulation
NASHVILLE, Tenn. — The Food and Drug Administration has approved a new formulation of a drug for treating acetaminophen poisoning.
Cumberland Pharmaceuticals announced Thursday that the agency had approved a version of Acetadote (acetylcysteine) injection that does not contain preservatives or stabilization and chelating agents, and will replace the currently marketed version. The drug originally was approved in 2004.
Acetaminophen, which appears in numerous over-the-counter and prescription drugs for treating pain, cough and cold, is the leading cause of poisonings reported by hospital emergency rooms in the United States. The FDA recently adopted a rule requiring acetaminophen in prescription painkillers not to exceed 325 mg due to the risk of serious liver injury in patients who overdose on the drug.