AbbVie, Inc. (ABBV - Free Report) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion, recommending marketing approval for risankizumab, its investigational interleukin-23 (IL-23) inhibitor, which has been developed for the treatment of moderate-to-severe plaque psoriasis. Risankizumab will be marketed by the trade name of Skyrizi.
AbbVie had filed the marketing application in the EU in May and in the United States in April, which was supported by data from four pivotal phase III studiesevaluating more than 2,000 patients. Data from these studies showed that more than half of the patients receiving risankizumab achieved complete skin clearance at one year.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 expected in the first half of the year.
AbbVie has developed risankizumab in collaboration with Boehringer Ingelheim and the candidate is also being evaluated in phase III studies in psoriasis, Crohn's disease and psoriatic arthritis.
AbbVie’s stock has declined 13.1% this year so far against an increase of 3.9% recorded by the industry.
AbbVie expects approval decision on 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. Approval and successful commercialization of upadacitinib are critical for long-term growth at AbbVie, especially as biosimilar competition looms for its blockbuster RA drug, Humira.
Several companies have made biosimilar versions of Humira. With Humira accounting for around 61% of AbbVie’s sales, the entry of biosimilars will have a huge impact on the company’s financials. Per settlements with seven manufacturers including Amgen (AMGN - Free Report) , Biogen (BIIB - Free Report) , Pfizer (PFE - Free Report) and Momenta, Humira biosimilars are expected to be launched in the United States in 2023. However, AbbVie faces direct biosimilar competition in Europe and other countries, which account for approximately 25% of total global Humira revenues. Humira biosimilars were first launched in the EU in October last year. In 2019, AbbVie expects a decline of 30%, or $2 billion, in international Humira sales.
AbbVie currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Zacks' Top 10 Stocks for 2019
In addition to the stocks discussed above, wouldn't you like to know about our 10 finest buy-and-holds for the year?
From more than 4,000 companies covered by the Zacks Rank, these 10 were picked by a process that consistently beats the market. Even during 2018 while the market dropped -5.2%, our Top 10s were up well into double-digits. And during bullish 2012 – 2017, they soared far above the market's +126.3%, reaching +181.9%.
This year, the portfolio features a player that thrives on volatility, an AI comer, and a dynamic tech company that helps doctors deliver better patient outcomes at lower costs.
See Stocks Today >>