AstraZeneca: EU recommends approval of Wainzua

(CercleFinance.com) - The Committee for Medicinal Products for Human Use (CHMP) in the European Union (EU) recommends the authorisation of Wainzua (eplontersen) in the EU for the treatment of adult patients with polyneuropathy associated with hereditary transthyretin-mediated amyloidosis.


If approved by the European Commission, Wainzua will be the only drug approved in the EU for the treatment of ATTRv-PN that can be self-administered monthly via an auto-injector.2-7.

ATTRv-PN is a debilitating disease that leads to peripheral nerve damage with motor disability within five years of diagnosis and, if left untreated, is usually fatal within a decade.

The CHMP based its opinion on the positive results of the Phase III NEURO-TTRansform study. Wainzua demonstrated a consistent and durable benefit by improving neuropathy impairment and quality of life compared to placebo.

A source at a Rare Diseases Unit in Italy said that having additional therapeutic options for amyloidosis, designed to reduce the production of the TTR protein at its source, could give patients more time and opportunities to do what matters most to them, and offer them the hope of living longer with a better quality of life.


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