A flexible Food and Drug Administration has once again rescued a biotech company seeking a drug approval based on flawed clinical trial data.
Alexion Pharma (ALXN) won agreement from FDA on Monday to expand the use of its top-selling, ultra-orphan medicine Soliris to treat patients with myasthenia gravis, a rare neuromuscular disease. FDA approved the Soliris label expansion even though the phase 3 clinical trial just missed its primary endpoint.
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