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news.Genzyme has announced that the Committee for Medicinal Products for Human Use has issued a positive opinion on the company's variation to produce Myozyme at the 4000 liter bioreactor scale at its manufacturing facility in Geel, Belgium.
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Myozyme is the only approved treatment for Pompe disease, a progressively debilitating disease that manifests as a broad spectrum of clinical symptoms.
The positive Committee for Medicinal Products for Human Use (CHMP) opinion is the final step before formal approval to produce and market Myozyme manufactured at the 4000 liter bioreactor scale in the EU, Norway and Iceland.
The 4000 liter manufacturing process is expected to help provide adequate supply of Myozyme in Europe for the foreseeable future. Myozyme is the only approved treatment for Pompe disease.
The committee’s opinion will be forwarded to the European Commission, which will make a final decision on the authorization. The Commission has 44 calendar days to act on the CHMP’s opinion. The European Commission generally follows the advice of the CHMP, but it is not obliged to do so.
Genzyme a biotechnology company is dedicated in developing drugs for serious diseases. The company’s products and services are focused on rare inherited disorders, kidney disease, orthopaedics, transplant, cancer, and diagnostic testing.