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AbbVie (ABBV) Gets CHMP Nod for Skyrizi in a Third Indication
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AbbVie (ABBV - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (“CHMP”) recommended approving its interleukin-23 (“IL-23”) inhibitor, Skyrizi (risankizumab) to treat moderate-to-severe Crohn’s disease (“CD”).
A final decision by the European Commission (EC) is expected in fourth-quarter 2022. If approved, the CD will be the third indication for risankizumab. Skyrizi is already approved in the European Union for two indications —plaque psoriasis and active psoriatic arthritis.
The CHMP decision is 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 with Skyrizi compared with those who received a placebo.
In the year so far, shares of AbbVie have declined 5.4% against the industry’s 3.3% fall.
Image Source: Zacks Investment Research
In June, Skyrizi was approved by the FDA for treating moderately to severely active CD. Similar to the EU, the drug is also approved in the United States for plaque psoriasis and active psoriatic arthritis indications.
Apart from the above indications, AbbVie is currently evaluating Skyrizi in a phase III study for ulcerative colitis.
AbbVie is developing Skyrizi in collaboration with Boehringer Ingelheim, with AbbVie leading the global development and commercialization of Skyrizi.
AbbVie is focused on strengthening its focus on new immunology medicines, Skyrizi and Rinvoq, to lessen its dependence on Humira, the company’s blockbuster drug. Humira’s sales are declining due to biosimilars eroding AbbVie’s yearly international sales. Humira biosimilars are expected to be launched in the United States next year.
Skyrizi and Rinvoq demonstrated differentiated clinical profiles compared to Humira and are already contributing meaningful revenues, including $4.6 billion in combined sales in 2021 and $3.25 billion in the first half of 2022.
With many new indications coming in the next couple of years, AbbVie expects sales of these two drugs to be higher and potentially replace Humira. The company also expects the combined sales of Skyrizi and Rinvoq to be more than $15 billion by 2025.
In the past 60 days, estimates for Kamada’s 2022 earnings per share have risen from 1 cent to 26 cents. Shares of Kamada have lost 28.4% in the year-to-date period.
The earnings of Kamada missed estimates in three of the last four quarters and beat the mark just once, witnessing a negative surprise of 212.50%, on average. In the last reported quarter, KMDA’s earnings beat estimates by 450%.
In the past 60 days, estimates for Morphic’s 2022 loss per share have narrowed from $3.47 to $1.80. Loss estimates for 2023 have narrowed from $3.96 to $3.62 during the same period. Shares of Morphic have lost 40.2% in the year-to-date period.
Earnings of Morphic beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 48.29%, on average. In the last reported quarter, MORF delivered an earnings surprise of 183.95%.
In the past 60 days, estimates for Sanofi’s 2022 earnings per share have increased from $4.09 to $4.14. Earnings estimates for 2023 have increased from $4.25 to $4.29 during the same period. Shares of Sanofi have lost 19% in the year-to-date period.
Earnings of Sanofi beat estimates in each of the last four quarters, witnessing a surprise of 9.37%, on average. In the last reported quarter, SNY delivered an earnings surprise of 8.24%.
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AbbVie (ABBV) Gets CHMP Nod for Skyrizi in a Third Indication
AbbVie (ABBV - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (“CHMP”) recommended approving its interleukin-23 (“IL-23”) inhibitor, Skyrizi (risankizumab) to treat moderate-to-severe Crohn’s disease (“CD”).
A final decision by the European Commission (EC) is expected in fourth-quarter 2022. If approved, the CD will be the third indication for risankizumab. Skyrizi is already approved in the European Union for two indications —plaque psoriasis and active psoriatic arthritis.
The CHMP decision is 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 with Skyrizi compared with those who received a placebo.
In the year so far, shares of AbbVie have declined 5.4% against the industry’s 3.3% fall.
Image Source: Zacks Investment Research
In June, Skyrizi was approved by the FDA for treating moderately to severely active CD. Similar to the EU, the drug is also approved in the United States for plaque psoriasis and active psoriatic arthritis indications.
Apart from the above indications, AbbVie is currently evaluating Skyrizi in a phase III study for ulcerative colitis.
AbbVie is developing Skyrizi in collaboration with Boehringer Ingelheim, with AbbVie leading the global development and commercialization of Skyrizi.
AbbVie is focused on strengthening its focus on new immunology medicines, Skyrizi and Rinvoq, to lessen its dependence on Humira, the company’s blockbuster drug. Humira’s sales are declining due to biosimilars eroding AbbVie’s yearly international sales. Humira biosimilars are expected to be launched in the United States next year.
Skyrizi and Rinvoq demonstrated differentiated clinical profiles compared to Humira and are already contributing meaningful revenues, including $4.6 billion in combined sales in 2021 and $3.25 billion in the first half of 2022.
With many new indications coming in the next couple of years, AbbVie expects sales of these two drugs to be higher and potentially replace Humira. The company also expects the combined sales of Skyrizi and Rinvoq to be more than $15 billion by 2025.
AbbVie Inc. Price
AbbVie Inc. price | AbbVie Inc. Quote
Zacks Rank & Stock to Consider
AbbVie currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the overall healthcare sector are Kamada , Morphic (MORF - Free Report) and Sanofi (SNY - Free Report) . While Kamada and Morphic sport a Zacks Rank #1 (Strong Buy), Sanofi carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Kamada’s 2022 earnings per share have risen from 1 cent to 26 cents. Shares of Kamada have lost 28.4% in the year-to-date period.
The earnings of Kamada missed estimates in three of the last four quarters and beat the mark just once, witnessing a negative surprise of 212.50%, on average. In the last reported quarter, KMDA’s earnings beat estimates by 450%.
In the past 60 days, estimates for Morphic’s 2022 loss per share have narrowed from $3.47 to $1.80. Loss estimates for 2023 have narrowed from $3.96 to $3.62 during the same period. Shares of Morphic have lost 40.2% in the year-to-date period.
Earnings of Morphic beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 48.29%, on average. In the last reported quarter, MORF delivered an earnings surprise of 183.95%.
In the past 60 days, estimates for Sanofi’s 2022 earnings per share have increased from $4.09 to $4.14. Earnings estimates for 2023 have increased from $4.25 to $4.29 during the same period. Shares of Sanofi have lost 19% in the year-to-date period.
Earnings of Sanofi beat estimates in each of the last four quarters, witnessing a surprise of 9.37%, on average. In the last reported quarter, SNY delivered an earnings surprise of 8.24%.