Operator
Good morning and thank you for standing by. Welcome to the AbbVie first-quarter 2021 earnings conference call. [Operator instructions] I would now like to introduce Ms. Liz Shea, vice president of investor relations.
You may begin.
Vice President of Investor Relations
Good morning and thanks for joining us. Also on the call with me today are Rick Gonzalez, chairman of the board and chief executive officer; Michael Severino, vice chairman and president; Rob Michael, executive vice president and chief financial officer; and Jeff Stewart, executive vice president, commercial operations. Joining us for the Q&A portion of the call is Laura Schumacher, vice chairman, external affairs, chief legal officer, and corporate secretary. Before we get started, I remind you that some statements we make today may be considered forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995.
AbbVie presents applications to FDA and EMA for approval of SKYRIZI in psoriatic arthritis
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AbbVie (ABBV) Submits Regulatory Applications for SKYRIZI (risankizumab) in Psoriatic Arthritis to FDA and EMA
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ABBVie today announced that it has submitted applications seeking approval for SKYRIZI ® to the U.S. Food and Drug Administration and for SKYRIZI ® to the European Medicines Agency 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 …
ABBVie (NYSE: ABBV) 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 andor non-b