Genzyme receives FDA approval for genetic disorder treatment Lumizyme

Genzyme gets FDA approval for Lumizyme

CAMBRIDGE, Mass. — Federal regulators approved Genzyme’s drug to treat a muscle development disease, sending shares of the Biotechnology company up 6 percent Tuesday.

The company already makes the drug Myozyme, which is also used to treat Pompe disease. gespacho

Manufacturing problems at the company’s Boston plant have forced the company to cut supplies of the drugs Cerezyme and Fabrazyme, which treat genetic conditions. Lumizyme, which was just approved by the Food and Drug Administration to treat Pompe disease, is made in Belgium.

Genzyme this week said it would pay a $175 million penalty for the manufacturing problems.

In June, Genzyme shut down its Boston plant for about three months to clean up viral contamination that had been slowing production. The virus was not harmful to people, but the shutdown was costly. During the fourth quarter, profit plunged 73 percent to $23.2 million as sales slumped.

In November, the FDA said it found tiny particles of trash in drugs made by Genzyme, including steel, rubber and fiber. The agency recommended that doctors closely inspect vials of four drugs made at the plant: Cerezyme, Fabrazyme, Myozyme and Thyrogen.

The company has been restructuring its manufacturing operations since January.

Shares of Genzyme Corp. rose $2.43 to $51.01 in afternoon trading. The stock has traded between $45.39 and $63.47 over the last 52 weeks.