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AbbVie's Psoriasis Drug Skyrizi Gets First Approval in Japan
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AbbVie Inc. (ABBV - Free Report) announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved its key pipeline candidate, risankizumab, for the treatment of adult patients with plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis. The interleukin-23 (IL-23) inhibitor will be marketed under the trade name of Skyrizi.
Following this nod, Japan became the first country to approve Skyrizi for patients suffering psoriatic disease and failing to show an adequate response to the conventional therapies.
The approval was based on the safety and efficacy data from the phase II/III studies, namely sustaIMM, ultIMMa-1 and IMMspire, which evaluated Skyrizi in the Japanese patients with plaque psoriasis, generalized pustular psoriasis and erythrodermic psoriasis. Also, a global phase II study evaluated Skyrizi for treating patients with active psoriatic arthritis, which also formed basis of its application filing in Japan
AbbVie has developed Skyrizi in collaboration with the privately held Boehringer Ingelheim.
Shares of AbbVie have declined 13.7% so far this year against the industry’s increase of 3.7%.
We would like to remind investors that earlier this month, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion, recommending the marketing approval for Skyrizi to treat moderate-to-severe plaque psoriasis.
Notably, AbbVie had filed the marketing application in the EU last May and in the United States last April. AbbVie’s application will now be reviewed by the European Commission, which will announce its decision in two months’ time. The FDA’s decision is also awaited in the first half of 2019.
AbbVie expects an approval for another key pipeline candidate, upadacitinib, this year. Upadacitinib, an oral investigational JAK inhibitor, has been developed for the treatment of adult patients with moderate-to-severe rheumatoid arthritis (RA). The nod and the successful commercialization of upadacitinib are crucial for long-term growth at AbbVie, especially as a biosimilar competition looms large on its blockbuster RA drug, Humira.
Several companies made biosimilar versions of Humira. With Humira accounting for around 61% of AbbVie’s sales, the entry of biosimilars will leave a huge impact on the company’s financials. Per settlements with a set of seven manufacturers including Amgen (AMGN - Free Report) , Biogen (BIIB - Free Report) , Pfizer (PFE - Free Report) , Momenta among others, Humira biosimilars are expected to be launched across the United States in 2023. However, AbbVie faces a direct biosimilar competition in Europe and other countries, accounting for approximately 25% of the total global Humira revenues. Humira biosimilars were first unveiled in the EU last October. In 2019, AbbVie fears a 30% plunge or a $2-billion decline in the international Humira sales.
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AbbVie's Psoriasis Drug Skyrizi Gets First Approval in Japan
AbbVie Inc. (ABBV - Free Report) announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved its key pipeline candidate, risankizumab, for the treatment of adult patients with plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis. The interleukin-23 (IL-23) inhibitor will be marketed under the trade name of Skyrizi.
Following this nod, Japan became the first country to approve Skyrizi for patients suffering psoriatic disease and failing to show an adequate response to the conventional therapies.
The approval was based on the safety and efficacy data from the phase II/III studies, namely sustaIMM, ultIMMa-1 and IMMspire, which evaluated Skyrizi in the Japanese patients with plaque psoriasis, generalized pustular psoriasis and erythrodermic psoriasis. Also, a global phase II study evaluated Skyrizi for treating patients with active psoriatic arthritis, which also formed basis of its application filing in Japan
AbbVie has developed Skyrizi in collaboration with the privately held Boehringer Ingelheim.
Shares of AbbVie have declined 13.7% so far this year against the industry’s increase of 3.7%.
We would like to remind investors that earlier this month, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion, recommending the marketing approval for Skyrizi to treat moderate-to-severe plaque psoriasis.
Notably, AbbVie had filed the marketing application in the EU last May and in the United States last April. AbbVie’s application will now be reviewed by the European Commission, which will announce its decision in two months’ time. The FDA’s decision is also awaited in the first half of 2019.
AbbVie expects an approval for another key pipeline candidate, upadacitinib, this year. Upadacitinib, an oral investigational JAK inhibitor, has been developed for the treatment of adult patients with moderate-to-severe rheumatoid arthritis (RA). The nod and the successful commercialization of upadacitinib are crucial for long-term growth at AbbVie, especially as a biosimilar competition looms large on its blockbuster RA drug, Humira.
Several companies made biosimilar versions of Humira. With Humira accounting for around 61% of AbbVie’s sales, the entry of biosimilars will leave a huge impact on the company’s financials. Per settlements with a set of seven manufacturers including Amgen (AMGN - Free Report) , Biogen (BIIB - Free Report) , Pfizer (PFE - Free Report) , Momenta among others, Humira biosimilars are expected to be launched across the United States in 2023. However, AbbVie faces a direct biosimilar competition in Europe and other countries, accounting for approximately 25% of the total global Humira revenues. Humira biosimilars were first unveiled in the EU last October. In 2019, AbbVie fears a 30% plunge or a $2-billion decline in the international Humira sales.
Zacks Rank
AbbVie currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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