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Givlaari (givosiran)

EMA’s transformative treatments of 2020

24 February 2021 | By Hannah Balfour (European Pharmaceutical Review)

In this article, we summarise the trial findings for the European Medicines Agency’s 13 most transformative therapies of 2020.

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EC grants marketing authorisation to Givlaari^® (givosiran) for acute hepatic porphyria

4 March 2020 | By Hannah Balfour (European Pharmaceutical Review)

The developers of givosiran announced the European Commission (EC) has granted the drug marketing authorisation based on results of the Phase III ENVISION trial.

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CHMP recommends fifteen therapeutics at latest meeting

3 February 2020 | By European Pharmaceutical Review

The EMA’s human medicines committee (CHMP) recommended fifteen medicines for various approvals at its January 2020 meeting; with ten drugs receiving marketing authorisation recommendations and five receiving positive opinions for specific treatments.

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First treatment for inherited rare disease approved by the FDA

22 November 2019 | By Rachael Harper (European Pharmaceutical Review)

Givlaari (givosiran) has been approved by the FDA for the treatment of adult patients with the rare genetic disorder, acute hepatic porphyria.

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Recommended

Givlaari (givosiran)

EMA’s transformative treatments of 2020

EC grants marketing authorisation to Givlaari® (givosiran) for acute hepatic porphyria

CHMP recommends fifteen therapeutics at latest meeting

First treatment for inherited rare disease approved by the FDA

EC grants marketing authorisation to Givlaari^® (givosiran) for acute hepatic porphyria