FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Europeans Give Nod to Waylivra as Diet Adjunct

May 20, 2019
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Akcea Therapeutics have won European approval for Waylivra, a treatment for an ultra-rare enzyme disease, less than a year after the FDA gave it the thumbs down.

The company will begin dispensing Waylivra (volanesorsen) in Germany this year and roll it out throughout the EU beginning next year. It’s been approved as an adjunct to diet for patients with familial chylomicronemia syndrome who are at risk of pancreatitis.

Familial chylomicronemia syndrome is the result of impaired function of the enzyme lipoprotein lipase, which can cause a host of organ problems, including pancreatitis.

Akcea received a complete response letter from the FDA last year, citing  concerns about the drug causing dangerous dips in patients’ platelet counts.

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