Sorry to be late posting today with the Weekly Roundup. I had a lot of meetings Friday. Sometimes when that happens, I just skip it, but there were some interesting developments last week, particularly related to decisions on some pending drug applications, so I’m coming in with the Weekly Roundup a day late, and if I check, I bet I’m a dollar short too.
- Lilly Gets Thumbs Down on Zyprexa - The Indiana Star reported that the FDA decided not to approve Lilly’s once a month injectable Zyprexa for the treatment of schizophrenia. According to the report, the FDA had concerns about excessive sedation associated with the treatment and requested further studies, though it is not clear then why an approvable letter was not issued instead of a non-approval. It is even more curious given that the sedation described is rare and that the advisory committee recommended approval. Given the fact that compliance is an important issue in the treatment of schizophrenics, one would think that the benefit far outweighs the risk. The conditions probably make Lilly want to appeal, but the formal dispute resolution process is not stacked in the favor of one making such an appeal and has usually been the realm of small, inexperienced and many times foreign companies.
- FDA Goes Through the Wringer on the Hill – Congresswoman Rosa DeLauro blasted the FDA once again during hearings this week on Capitol Hill during Janet Woodcock’s testimony before the House Appropriations Subcommittee on Agriculture, Rural Development, FDA and Related Agencies. It serves as further evidence that the FDA and industry are in for a very rough year, to say the least.
- Parkinson’s Disease Drug Gets Not-Approvable Action – In another rejection, the FDA refused a Parkinson’s Drug advanced by Kyowa Hakko based on concerns of efficacy. The primary endpoints were missed in two out of three Phase III clinical trials, again raising the point that when a candidate misses endpoints, it is very tough to gain approval.
- The Heparin Crisis Continues – Baxter International Inc. announced on the 28th of February that the company is proceeding with the voluntary recall of all remaining lots and doses of its heparin sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products.The company initially recalled nine lots of heparin sodium injection multi-dose vials on January 17, 2008 as a precautionary measure due to a higher than usual number of reports of adverse patient reactions involving the product and suspended production earlier this month.
- Upcoming Meeting on QT Prolongation in Drug Development – QT Prolongation is something most people haven’t even heard of, but if you have been to an advisory committee meeting in the past few years, it will ring bells. It has become a matter of scrutiny for many kinds of drugs where there might be a cardiac-associated adverse event. The FDA is co-sponsoring a meeting with the Heart Rhythm Society to focus on the new direction in the development of pharmaceutical agents as well as the practical challenges and possible solutions.