New AbbVie drug wins FDA approval

The injectable, which can be administered by a doctor or self-administered after training, has also been approved in Canada for plaque psoriasis and in Japan for plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis. Meanwhile, the European Medicines Agency is evaluating SKYRIZI in the treatment of plaque psoriasis.

AbbVie collaborated on the drug with Boehringer Ingelheim, paying the German drugmaker $595 million in 2016 for the rights to take it to market. Phase 3 trials of SKYRIZI for the treatment of Crohn’s disease and psoriatic arthritis are ongoing, AbbVie said in a statement, noting it’s also being investigated as a treatment for ulcerative colitis.

Another promising pipeline drug from AbbVie, upadacitinib, is under review by the FDA and European Medicines Agency for the treatment of rheumatoid arthritis. The company expects risankizumab and upadacitinib to generate a combined $10 billion or more in annual sales by 2025.

“Those two would be important supplemental products because Humira is an autoimmune drug, as well,” Ashtyn Evans, a health care analyst at Edward Jones, said in January. “Getting those approvals in that market that they’re really good at will be important for the growth story.”

Humira sales neared $20 billion last year, accounting for about 60 percent of the company’s revenue.

“SKYRIZI builds on AbbVie’s legacy in immunology, expanding our portfolio to help meet the evolving needs in psoriatic disease and reinforcing our continued pursuit of innovations that improve care for people living with immune-mediated conditions,” Dr. Michael Severino, vice chairman and president of AbbVie, said in the statement.

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