Takhzyro - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation.

lanadelumab

Opinion

On 14 September 2023 , the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Takhzyro. The marketing authorisation holder for this medicinal product is Takeda Pharmaceuticals International AG Ireland Branch.

The CHMP adopted an extension to the existing indication as follows:1

Takhzyro is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 2 years and older.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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¹New text in bold, removed text as strikethrough

CHMP post-authorisation summary of positive opinion for Takhzyro (X-0032-G)

AdoptedReference Number: EMA/CHMP/400511/2023

Key facts

• Name of medicine:
  Takhzyro
• EMA product number:
  EMEA/H/C/004806
• Active substance:
  lanadelumab
• International non-proprietary name (INN) or common name:
  lanadelumab
• Therapeutic area (MeSH):
  Angioedemas, Hereditary
• Anatomical therapeutical chemical (ATC) code:
  B06AC05
• Accelerated assessment:

  This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

• Orphan:

  This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

• Marketing authorisation holder:
  Takeda Pharmaceuticals International AG Ireland Branch
• Date of opinion:
  14/09/2023
• Status:
  Positive