Last month, the US Food and Drug Administration had rejected Genzyme's drug for the treatment of Pompe disease, Lumizyme. The FDA and the drug manufacturer have now reportedly agreed on a plan to ensure that the medicine is approved. The arrangement was shared by the pharma company on Thursday.
Earlier, the company had been seeking approval for the drug's version which was developed in 2,000-liter bioreactors. But now, the plan has been modified and the Cambridge, Massachusetts based firm will look to gain an approval for the 4,000 liter version produced at its plant in Geel, Belgium.
By doing this, the company looks to do away with all the issues that the FDA had raised with regards to its Allston plant.
"While some regulatory risk and timeline uncertainty remain, we believe this is a positive step", said Brian Abrahams, an analyst at Oppenheimer & Co.
Genzyme now says that under the new application, the drug's approval from the FDA could come as early as next year. As a treatment for a rare muscle disorder, called Pompe disease, Lumizyme is marketed outside the US as Myozyme.
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