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FDA to review Alexion drug as treatment for neuromuscular disease

Alexion Pharmaceuticals Inc.’s drug Soliris will be reviewed by the U.S. Food and Drug Administration as a potential treatment for a debilitating neuromuscular disease (myasthenia gravis), the company announced Wednesday.

The chronic, progressive disease leads to varying degrees of skeletal muscle weakness.

If approved, Soliris, also known as eculizumab, would be the first and only drug of its kind to treat “antibody-positive” patients with so-called refractory generalized myasthenia gravis, the company said.

Despite existing treatment options for the disease, patients face severe complications, including difficulty walking, talking, swallowing, and breathing normally, said Martin Mackay, executive vice president and global head of R&D at Alexion.

Soliris is currently used to treat certain rare blood disorders.

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