21st Oct 2024 08:35
(Alliance News) - AstraZeneca PLC on Monday said its Wainzua treatment has been been recommended for EU approval to treat adult patients with polyneuropathy associated with hereditary transthyretin-mediated amyloidosis.
The Cambridge, England-based pharmaceutical and biotechnology company developed Wainzua, or eplontersen, in partnership with Californian biotechnology firm Ionis Pharmaceuticals Inc.
Wainzua is a medication used to treat transthyretin-mediated amyloidosis, a rare disease that leads to peripheral nerve damage with motor disability within five years of diagnosis, and is generally fatal within a decade without treatment.
Wainzua has been recommended for approval in the EU by the Committee for Medicinal Products for Human Use.
The decision was based on positive results from phase 3 trials which showed that through 66 weeks, patients treated with Wainzua demonstrated consistent and sustained benefit on the co-primary endpoints of serum transthyretin concentration and neuropathy impairment.
Ruud Dobber, executive vice president, BioPharmaceuticals Business Unit, AstraZeneca, said: "Due to the progressive nature of polyneuropathy of hereditary transthyretin-mediated amyloidosis, it is critical to have timely diagnosis and new therapies to help people have greater control over this potentially fatal disease. Today's recommendation brings Wainzua one step closer for patients in Europe, and if approved, will offer a new treatment option that can provide consistent [transthyretin protein] suppression and results in improved quality of life."
AstraZeneca shares were up 0.2% at 11,974.00 pence each in London on Monday morning.
By Elijah Dale, Alliance News reporter
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