UncategorizedUncategorizedClinical Trial Updates (SCD)

Oxbryta®

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  • Product Information

    Product Information

    Scientific name: Voxelotor
    Brand name: Oxbryta
    RESPONSIBLE: Global Blood Therapeutics [subsidiary of Pfizer]

  • Clinical Trial/Study Information

    Clinical Trial/Study Information

    Last update: 22/6/2023

    Trial Name: —
    Code: —
    Phase: —
    Eligible patient diagnosis: —
    No. of Patients enrolled: —
    Study Sites: — Sites per country

    Anticipated completion date: —
    Scope of the Study / Aim: —

  • Regulatory Information

    Regulatory Information

    Status: Authorised

    Additional notable points:

    • —

Update: 30 September 2023

No update available.

 

Update: 30 June 2023

No update available.

 

Update: 31 March 2023

Preliminary draft guidance from England’s HTA body NICE states the product is not an acceptable use of National Health Service resources.

Previously the UK regulatory body MHRA grants marketing authorisation approval in 2022.

Oxbryta® (voxelotor) is intended for the treatment of haemolytic anaemia due to Sickle Cell Disease (SCD) in eligible adult and paediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide (hydroxyurea).

NICE will proceed to a public consultation on the preliminary recommendation, before the final recommendation later in the year.

Sources: https://pink.pharmaintelligence.informa.com/PS147563/Blow-For-Pfizer-As-UKsNICE-Rejects-Oxbryta-For-Sickle-Cell-Disease
https://www.pfizer.co.uk/news/media/pfizers-response-nice-decision-oxbryta

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