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AbbVie's (ABBV) Skyrizi Gets EU Nod for Crohn's Disease
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AbbVie (ABBV - Free Report) announced that the European Commission has granted approval to its drug Skyrizi (risankizumab) to treat moderate-to-severe Crohn’s disease (“CD”).
Crohn’s disease is the third approved indication for Skyrizi in Europe. The drug is the first specific IL-23 inhibitor approved for CD in the European Union. The approval is for patients who have had an inadequate response, lost response or were intolerant to conventional or biologic therapy.
In the United States, Skyrizi was approved for CD in June. Skyrizi is already approved in the European Union, the United States and some other countries for two other indications — plaque psoriasis and active psoriatic arthritis.
The approval for the CD indication in European Union was expected as in September, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (“CHMP”) had recommended approving Skyrizi for CD.
The approval for CD was based on positive data from three phase III studies, namely ADVANCE, MOTIVATE and FORTIFY, which evaluated the safety and efficacy of Skyrizi in CD patients. All three studies achieved the co-primary endpoints of clinical remission and endoscopic response in participants administered Skyrizi compared with those who received a placebo.
AbbVie’s stock has risen 17.7% this year so far, compared with an increase of 7.8% for the industry.
Image Source: Zacks Investment Research
Skyrizi commands approximately 27% share of the total prescriptions in the U.S. psoriasis biological market. AbbVie also enjoys a leading market share in several international geographies. On the third-quarter conference call in October, AbbVie had said it expects Skyrizi sales for the new Crohn’s disease indication to ramp significantly over the next several quarters as early prescription trends are encouraging. With further approval received in Europe for CD indication, sales are expected to be higher.
Skyrizi, which was launched in 2019, generated sales of $3.59 billion in the first nine months of 2022.
Skyrizi and AbbVie’s other new successful immunology medicine, Rinvoq established outstanding launch trajectories bolstered by the approval in new indications. With approvals for such new indications, sales of these drugs could be higher in 2023/2024 and have the potential to replace Humira when generics are launched in the United States in 2023. Humira is AbbVie’s blockbuster anti-inflammatory product.
Vertex Pharmaceuticals’ stock has risen 43.9% this year. Estimates for Vertex’s 2022 earnings have gone up from $14.21 to $14.61 per share, while that for 2023 have increased from $15.18 to $15.60 per share over the past 30 days.
Vertex has a four-quarter earnings surprise of 3.16%, on average.
Estimates for Merck’s 2022 earnings per share have increased from $7.30 per share to $7.38, while that for 2023 have increased from $7.20 per share to $7.34 in the past 30 days. Merck’s stock is up 39.5% in the year-to-date period.
Merck beat earnings expectations in all the trailing four quarters. The company delivered a four-quarter earnings surprise of 16.07%, on average.
Estimates for Gilead’s 2022 earnings per share have increased from $6.54 per share to $7.09 per share, while that for 2023 have increased from $6.51 per share to $6.79 per share in the past 30 days. Gilead’s stock is up 17.6% in the year-to-date period.
Gilead beat earnings expectations in three of the trailing four quarters. The company delivered a four-quarter earnings surprise of 0.36%, on average.
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AbbVie's (ABBV) Skyrizi Gets EU Nod for Crohn's Disease
AbbVie (ABBV - Free Report) announced that the European Commission has granted approval to its drug Skyrizi (risankizumab) to treat moderate-to-severe Crohn’s disease (“CD”).
Crohn’s disease is the third approved indication for Skyrizi in Europe. The drug is the first specific IL-23 inhibitor approved for CD in the European Union. The approval is for patients who have had an inadequate response, lost response or were intolerant to conventional or biologic therapy.
In the United States, Skyrizi was approved for CD in June. Skyrizi is already approved in the European Union, the United States and some other countries for two other indications — plaque psoriasis and active psoriatic arthritis.
The approval for the CD indication in European Union was expected as in September, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (“CHMP”) had recommended approving Skyrizi for CD.
The approval for CD was based on positive data from three phase III studies, namely ADVANCE, MOTIVATE and FORTIFY, which evaluated the safety and efficacy of Skyrizi in CD patients. All three studies achieved the co-primary endpoints of clinical remission and endoscopic response in participants administered Skyrizi compared with those who received a placebo.
AbbVie’s stock has risen 17.7% this year so far, compared with an increase of 7.8% for the industry.
Image Source: Zacks Investment Research
Skyrizi commands approximately 27% share of the total prescriptions in the U.S. psoriasis biological market. AbbVie also enjoys a leading market share in several international geographies. On the third-quarter conference call in October, AbbVie had said it expects Skyrizi sales for the new Crohn’s disease indication to ramp significantly over the next several quarters as early prescription trends are encouraging. With further approval received in Europe for CD indication, sales are expected to be higher.
Skyrizi, which was launched in 2019, generated sales of $3.59 billion in the first nine months of 2022.
Skyrizi and AbbVie’s other new successful immunology medicine, Rinvoq established outstanding launch trajectories bolstered by the approval in new indications. With approvals for such new indications, sales of these drugs could be higher in 2023/2024 and have the potential to replace Humira when generics are launched in the United States in 2023. Humira is AbbVie’s blockbuster anti-inflammatory product.
Zacks Rank & Stocks to Consider
AbbVie currently carries a Zacks Rank #3 (Hold). Some better-ranked large drugmakers are Vertex Pharmaceuticals (VRTX - Free Report) , Merck (MRK - Free Report) and Gilead Sciences (GILD - Free Report) , all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Vertex Pharmaceuticals’ stock has risen 43.9% this year. Estimates for Vertex’s 2022 earnings have gone up from $14.21 to $14.61 per share, while that for 2023 have increased from $15.18 to $15.60 per share over the past 30 days.
Vertex has a four-quarter earnings surprise of 3.16%, on average.
Estimates for Merck’s 2022 earnings per share have increased from $7.30 per share to $7.38, while that for 2023 have increased from $7.20 per share to $7.34 in the past 30 days. Merck’s stock is up 39.5% in the year-to-date period.
Merck beat earnings expectations in all the trailing four quarters. The company delivered a four-quarter earnings surprise of 16.07%, on average.
Estimates for Gilead’s 2022 earnings per share have increased from $6.54 per share to $7.09 per share, while that for 2023 have increased from $6.51 per share to $6.79 per share in the past 30 days. Gilead’s stock is up 17.6% in the year-to-date period.
Gilead beat earnings expectations in three of the trailing four quarters. The company delivered a four-quarter earnings surprise of 0.36%, on average.