Looks like Genzyme
While that's bad news, the good news is that it sounds like Genzyme is headed for an "accelerated" approval. The company said that the FDA was willing to approve the larger-scale production on the condition that Genzyme test the drug from the new, bigger batches after approval to show that it works. The agency and the FDA just need to agree on the trial details.
This type of accelerated approval isn't too common. However, the agency does invoke it from time to time when there's evidence that a drug works for a disease with unmet needs, but the FDA isn't fully convinced. Genentech's
The three-month delay gives the agency additional time to review Genzyme's Risk Evaluation and Mitigation Strategy (REMS). The company submitted its REMS for the drug after the FDA advisory panel expressed concern about giving the less-tested version to infants. The FDA requires REMS for some drugs to limit their off-label use. While they can be as restrictive as the one for Biogen Idec
While it doesn't look like Genzyme will get its Thanksgiving stuffing from the FDA, hopefully the agency will give it some Valentine's Day candy.
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