Genzyme drug receives 6-month review

Genzyme revealed this week that its Pompe disease therapy Lumizyme (alglucosidase alfa) has been granted a six-month review period by the Food and Drug Administration (FDA).

The resubmission of the drug’s paperwork has been filed by the body as a class 2 complete response, which carries a review timeframe of six months.

Enrolment in the Alglucosidase Alfa Temporary Access Programme (ATAP) resumed last month, an initiative that allows those severely affected by Pompe disease to access the treatment prior to its commercial approval.

It is provided free of charge by the organisation to around 170 patients and the project has been in place since 2007.

In Europe and other markets, Lumizyme is marketed under the name Myozyme and has been commercially approved for the treatment of Pompe disease in approximately 40 countries.

Last week, Genzyme published its preliminary financial results for the final quarter of 2009, revealing revenues of $1.08 billion (662.3 million pounds) for the period.