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Genzyme Lemtrada’s Momentum Halts With FDA “Refuse-To File” Letter

 
• By Martin Berman-Gorvine

The company says a data formatting issue was the reason FDA declined to accept the supplemental application for alemtuzumab for relapsing multiple sclerosis.

Genzyme Corp., Sanofi’s rare disease unit, has seen a setback to its costly strategy of withdrawing the leukemia treatment alemtuzumab from the market to make way for an expected relapsing multiple sclerosis indication, with FDA sending the company a “refuse-to-file” letter for the new indication.

Genzyme said Aug. 27 it had received the letter for Lemtrada, the proposed brand name for alemtuzumab in the MS...

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