Ionis Pharmaceuticals (IONS) said Monday the Committee for Medicinal Products for Human Use has recommended approval of the company and AstraZeneca's (AZN) Wainzua drug to treat hereditary transthyretin-mediated amyloidosis in the European Union.
The recommendation is for the treatment of adult patients with stage 1 or stage 2 polyneuropathy, the company said.
The recommendation was based on a phase 3 trial, which showed that patients treated with Wainzua "demonstrated consistent and sustained benefit on the co-primary endpoints of serum transthyretin concentration and neuropathy impairment," Ionis said.
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