Ionis, AstraZeneca going to FDA with PhIII data in hand; Glaukos touts double PhIII win in eye implant
Ionis and AstraZeneca are hoping its latest results net an FDA approval.
The two companies presented their latest Phase III results from a 35-week analysis of the Phase III trial, dubbed NEURO-TTRansform, of AstraZeneca’s eplontersen in patients with the rare disease known as hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN).
According to Ionis on Wednesday, Phase III had a positive outlook as eplontersen achieved an 81.2% reduction of serum transthyretin (TTR) concentration in patients compared to baseline, demonstrating reduced TTR protein production. This hit the co-primary endpoint of the trial and earned a p-value of p=<0.0001.
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