Genzyme Corp., a Cambridge biotechnology company, said that it has submitted the final documentation to address all items in the Food and Drug Administration's complete response letter for Lumizyme, a version of its drug for Pompe disease made in larger batches at its Allston plant.
The submission included clinical data requested by the FDA from Genzyme's Pompe Registry, said Genzyme, which disclosed in March that it had failed to win approval for Lumizyme. (To read a Bloomberg News story from then, please click here.)
Genzyme said today that it expects that the FDA will expedite the review process.
"Genzyme and the FDA are also in active discussion regarding the submission of an sBLA for the 4,000 L-scale manufacturing process," Genzyme said in a press release. "The company and the FDA are working collaboratively to determine the most expeditious path toward approval. Genzyme anticipates filing its submission later this quarter."
Pompe disease can result in a sugar build-up in the body that can harm muscles, internal organs, and the nervous system.
Genzyme already has approval for a version of the drug made at its Framingham plant; that drug is called Myozyme.
To read Genzyme's press release , please click here.
(By Chris Reidy, Globe staff)