Looks like Genzyme (NASDAQ:GENZ) won't be getting that gross-margin stuffing to go with its turkey after all. The Food and Drug Administration has pushed back its decision date on whether to approve larger-scale production of the company's enzyme replacement Myozyme to Feb. 28th.
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 (NYSE:DNA) Avastin for breast cancer and Merck's (NYSE:MRK) Isentress for HIV were both approved under this accelerated system.
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 (NASDAQ:BIIB) and Elan's (NYSE:ELN) Tysabri -- which enrolls patients in a special program -- Myozyme's will probably just cover additional literature to doctors, ensuring that they know the difference between the two products.
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.
Further fast-growing Foolishness:
- Find out about stocks you'll wish you'd bought.
- See the future and buy the right stocks.
- Genzyme is a five-star stock poised to pop.
