Joe Flaherty (Longford-Westmeath, Fianna Fail)
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280. To ask the Minister for Health if he will ensure that his Department monitors and tracks the development of the new drug omaveloxolone which presents the first real breakthrough treatment for Friedreich’s ataxia patients (details supplied). [4849/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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Omaveloxolone is currently under clinical investigation for a variety of indications, including Friedreich's ataxia. Currently, Omaveloxolone is not authorised in either the U.S. or the European Union.

If the safe and efficacious use of Omaveloxone in the treatment of Friedreich's ataxia is demonstrated through successful clinical trials, the marketing authorisation holder may choose to apply to the European Medicines Agency or the Health Products Regulatory Authority (HPRA), the competent authority for medicines in Ireland, to place the medicine on the market. The decision to make such an application can only be made by the marketing authorisation holder. It is important to note that, as Minister for Health, I have no role in the authorisation process for medicinal products.

As part of the marketing authorisation application process, the applicant company must provide evidence that the medicine adheres to clear and predefined standards of quality, safety, and efficacy, relevant to its proposed therapeutic use. This takes the form of a dossier including details of all the trials and studies undertaken of the active substance and the final pharmaceutical product, including preclinical studies, clinical trials and manufacturing, and analysis data.

A marketing authorisation is granted on the basis of a favourable benefit versus risk balance for specific therapeutic indications, having regard to the quality, safety, and efficacy of the product for the proposed conditions of use.