AbbVie (ABBV) Receives Positive CHMP Opinion for Change in Humira Marketing Approval

November 11, 2016 7:39 AM EST

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On 10 November 2016, 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 Humira. The marketing authorisation holder for this medicinal product is AbbVie Ltd. (NYSE: ABBV).

The CHMP adopted an extension to an existing indication as follows2:

Hidradenitis suppurativa (HS)

Humira is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents patientsfrom 12 years of age with an inadequate response to conventional systemic HS therapy”

For information, the full indications for Humira will be as follows:

Rheumatoid arthritis

Humira in combination with methotrexate, is indicated for:

  • the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
  • the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.

Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

Humira has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.

1 Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion
2 New text in bold, removed text as strikethrough

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