Genzyme's Lumizyme Receives FDA Approval

The FDA's decision to grant full approval to Lumizyme for Pompe Disease came earlier than expected.
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CAMBRIDGE, Mass. (

TheStreet

) --The U.S. Food and Drug Administration approved

Genzyme's

(GENZ)

Lumizyme as a treatment for Pompe disease, a rare genetic disorder, the agency said Tuesday in a statement.

The FDA decision to approve Lumizyme came earlier than expected and sent Genzyme shares up 6% to $51.38, bucking the downtrend for most stocks Tuesday.

The FDA wasn't expected to make an approval decision on Lumizyme until June 17, and even then, investors were worried that the agency would delay the drug's approval due to Genzyme's manufacturing problems.

Currently, the only other treatment for Pompe disease available in the U.S. is Myozyme, also made by Genzyme. But well-documented manufacturing problems at Genzyme's facilities in Boston have led to supply shortages and forced the company to ration Myozyme to treat only infants and young children with a more aggressive form of the disease.

The approval of Lumizyme, which Genzyme makes in a manufacturing plant located in Belgium, is expected to help alleviate that shortage and allow older and less sick Pompe disease patients to begin treatment.

In Pompe disease, a gene mutation prevents the body from making an enzyme necessary for proper muscle functioning. Without the enzyme action, glycogen builds up in the cells and, ultimately, weakens the heart and muscles.

-- Reported by Adam Feuerstein in Boston.

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