Breakthrough's Achilles Heel: Alexion’s Newly Acquired Kanuma Delayed By Manufacturing
This article was originally published in The Pink Sheet Daily
FDA extends the PDUFA date for enzyme replacement therapy by three months so agency can review chemistry, manufacturing and controls information; another drug, Strensiq, is also pending at FDA without any action.
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Kanuma, the first approved treatment for lysosomal acid lipase deficiency, will launch in January at an average annual treatment cost of $310,000.
Alexion plans to use voucher for one of its own products and might be targeting its next-generation version of blockbuster Soliris.
The latest drug development news and highlights from our FDA Performance Tracker.