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    Has all of the relevant evidence been taken into account?

  • Question on Consultation

    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?

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    Are the recommendations sound and a suitable basis for guidance to the NHS?

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2 Information about donidalorsen

Anticipated marketing authorisation indication

2.1

This draft guidance is being issued for consultation before donidalorsen (Dawnzera, Otsuka) has a licence for this indication in the UK. Any recommendations or conclusions in this document are provisional and dependent on the granting of a marketing authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA). The evaluation and consultation processes do not pre-empt, influence or replace the MHRA's independent regulatory assessment. Final guidance will only be published when a marketing authorisation is granted.

Dosage in the marketing authorisation

2.2

The dosage schedule will be available in the summary of product characteristics for donidalorsen.

Price

2.3

The list price of the 80-mg donidalorsen prefilled pen is currently confidential.

2.4

The company has a commercial arrangement, which would have applied if donidalorsen had been recommended.

Sustainability

2.5

Information on the Carbon Reduction Plan for UK carbon emissions for Otsuka will be included here when guidance is published.