Skyrizi goes for psoriatic arthritis

[Fred]

Following this thread [thread=7001] AbbVie have applied to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for approval to treat psoriatic arthritis.

Quote:

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AbbVie today announced that it has submitted applications seeking approval for SKYRIZI® (risankizumab-rzaa, 150 mg) to the U.S. Food and Drug Administration (FDA) and for SKYRIZI® (risankizumab, 150 mg) to the European Medicines Agency (EMA) for the treatment of adults with active psoriatic arthritis.1 The submissions were supported by two pivotal Phase 3 studies, KEEPsAKE-1 and KEEPsAKE-2, which evaluated SKYRIZI in adults with active psoriatic arthritis including those who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

"Most patients living with psoriatic arthritis experience both skin and joint disease which can be especially burdensome. Despite advancements, many patients cannot find relief from the signs and symptoms of this disease," said Michael Severino, M.D., vice chairman and president, AbbVie. "We are dedicated to providing options that can help more patients living with psoriatic arthritis reach their treatment goals."

In the Phase 3 KEEPsAKE-1 and KEEPsAKE-2 studies, SKYRIZI demonstrated significant improvements in disease activity (as measured by ACR20 response and minimal disease activity), skin clearance (as measured by at least a 90 percent improvement in Psoriasis Area Severity Index [PASI 90]) and physical function (as measured by the Health Assessment Questionnaire Disability Index [HAQ-DI]) at week 24 versus placebo. In both studies, significantly more patients treated with SKYRIZI achieved the primary endpoint of ACR20 response at week 24 versus placebo. The safety profile of SKYRIZI in these studies was generally consistent with the safety profile of SKYRIZI in plaque psoriasis, with no new safety risks observed.

Source: abbvie.com

[KatT]

  one more!

[Caroline]

  one more!

Yes, that is because most medication for psoriasis also works for Psoriatic Arthritis.
And that is because it is essentially the same disease..

[Fred]

Update: The Committee for Medicinal Products for Human Use (CHMP) have recommended the approval of Skyrizi for psoriatic arthritis.

Usually that means it will soon be available for use in the EU.

[Kat]

Good to know

[Fred]

Update: The European Commission has approved Skyrizi for psoriatic arthritis.

The Marketing Authorization will be valid in all member states of the European Union, as well as Iceland, Liechtenstein, Norway and Northern Ireland.

[jiml]

Update: The European Commission has approved Skyrizi for psoriatic arthritis.

The Marketing Authorization will be valid in all member states of the European Union, as well as Iceland, Liechtenstein, Norway and Northern Ireland.

good news I'm pleased that northern Ireland is included

[Caroline]

Update: The European Commission has approved Skyrizi for psoriatic arthritis.

The Marketing Authorization will be valid in all member states of the European Union, as well as Iceland, Liechtenstein, Norway and Northern Ireland.

good news  I'm pleased that northern Ireland is included 

Certainly.. I am also very happy that Northern Ireland is included and even extremely happy that Liechtenstein is included.

[Fred]

Update: The U.S. Food and Drug Administration (FDA) has approved Syrizi (risankizumab) for the treatment of adults with active psoriatic arthritis (PsA),

[Caroline]

Update: The U.S. Food and Drug Administration (FDA) has approved Syrizi (risankizumab) for the treatment of adults with active psoriatic arthritis (PsA),

That means that it now will work as it is authorised !! Good for J!