By Mark Terry
AbbVie has submitted a Biologics License Application (BLA) to the U.S. FDAfor risankizumab, an interleukin-23 (IL-23) inhibitor for plaque psoriasis.
The application is based on data from four Phase III clinical trials: ultIMMA-1, 2, IMMhance and IMMvent. The drug met all co-primary and ranked secondary endpoints with no new safety problems.
The drug was developed in a collaboration with Boehringer Ingelheim.
In the trials, more than 2,000 patients were treated.
“The risankizumab submission represents an important milestone in our goal of advancing treatment for people living with immune-mediated diseases,” said Michael Severino, AbbVie’s executive vice president, research and development and chief scientific officer. “Risankizumab has the potential to be an important treatment option for people living with plaque psoriasis and we look forward to working with the FDA throughout the review process.”
AbbVie also announced positive data from its ongoing Phase IIB/III SELECT-SUNRISE clinical trial. This trial evaluated upadacitinib in Japanese patients for moderate to severe rheumatoid arthritis. The data showed that at 12 weeks, all doses, 7.5mg, 15mg, 30mg, once-daily, met the primary endpoint of ACR20alpha compared to placebo.
“We are encouraged by these data, which show that upadacitinib provides improvements in important measures such as achieving ACR response and clinical remission, in people living with rheumatoid arthritis in Japan,” Severino said in a statement. “SELECT-SUNRISE reflects our continued commitment to offering innovative solutions with the potential to improve the lives of Japanese patients living with this serious, debilitating condition.”
Upadacitinib was discovered and developed by AbbVie. It is an oral drug that inhibits JAK1, which is linked to various immune-mediated diseases, including rheumatoid arthritis, psoriatic arthritis, and Crohn’s disease. In addition to those diseases, the drug is being evaluated for ulcerative colitis, ankylosing spondylitis, atopic dermatitis and giant cell arteritis.
AbbVie will be releasing its first-quarter financials tomorrow. In the last quarter, it reported a 2.78% increase in earnings, which was more than most analysts expected. Generally, the stock has outperformed the industry this year, which may not be saying much. The industry has shown an overall drop of 4.3% and AbbVie’s have decreased 4.1%.
Shares are currently trading for $91.3. The 52-week high was $125.86 and the low was $64.61. Shares opened today at $90.96.