FDA Reviewers Fret Over Genzyme Drug
3 CommentsBy Ed Silverman // October 17th, 2008 // 12:03 pm
In studies, a new version of Genzyme’s Myozyme showed similar side effects to the existing version, which treats Pompe disease, but long-term exposure to the newer med was not adequately studied, according to FDA medical reviewers.
In documents posted on the agency web site in advance of an advisory committee meeting next Tuesday, the reviewers wrote that there was also not enough data to show the new version works in children, and FDA officials should consider limiting approval for adults only (here are the Genzyme briefing documents).
The FDA has already approved a version of Myozyme manufactured at a Genzyme facility that uses a 160-liter tank, but Genzyme wants to make the drug in a 2,000-liter tank. The FDA considers the version made at the larger facility to be a different product from the one from the smaller plant because of differences in carbohydrate structure, thus requiring a separate review (back story).
Jaynesday
Sounds similar to what Genzyme did with Seprafilm. They recieved fast track approval then proceeded to change their manufacturing process and testing procedures, with FDA approval. Seprafilm has been known (according to doctors evaluation) to cause deadly reactions in some patients and has over 250 listed adverse events on the FDA’s MAUDE database.
Scott
The irony here is that other protein-based medicines are already being outsourced to third-party manufacturers without having to undergo clinical trials. Two cases-in-point: since 2003 at least, Eli Lilly & Co. has had FDA approval to sell Humulin® R and Humalog® vials which are actually manufactured by Hospira, Inc.’s “One 2 One Contract Manufacturing Services” (known previously as Abbott Laboratories’ One2One Global Pharmaceutical Services which was spun-off as an independent company in 2004) at a facility in McPherson, KS. Aside from having the same master cell bank, nothing else has been required by the FDA other than an initial approval. I realize that Myozyme is a glycosated protein, whereas biosynthetic insulin is non-glycosated (and that insulin is governed by the by the Federal Food Drugs and Cosmetics Act, whereas Myozyme is governed by the Public Health Services Act), but the reality is that the FDA is making Genzyme jump through hoops for approval in this case, while Lilly got a rubber-stamp approval. The FDA is clearly inconsistent in its demands of biotech and pharma, which calls for Congressional investigation.
laura
I don’t know anything about Eli Lilly, but I do know a bit about Genzyme and, from what I can tell with regard to one particular medical device manufactured by Genzyme, the FDA has allowed them to quite literally get away with murder for a number of years. If the FDA appears to be cracking down on Genzyme, it may be because Genzyme has given them reason to.