NORTH CHICAGO, Ill., Feb. 19, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its New Drug Application (NDA) for upadacitinib for the treatment of adult patients with moderate to severe rheumatoid arthritis. Upadacitinib is an investigational once-daily oral JAK1-selective inhibitor being studied for multiple immune-mediated diseases.1-13 AbbVie anticipates a regulatory decision in Q3 2019.
The NDA is supported by data from the global upadacitinib SELECT Phase 3 rheumatoid arthritis program evaluating more than 4,000 patients with moderate to severe rheumatoid arthritis across five of six Phase 3 studies.3-7 In all SELECT Phase 3 studies, upadacitinib met all primary and ranked secondary endpoints. The most frequent serious adverse events were infections.3-7 Top-line results from these clinical studies were previously announced.
Upadacitinib is also under review by the European Medicines Agency for the treatment of adult patients with moderate to severe rheumatoid arthritis.
About the SELECT Study Program3-8
The robust SELECT Phase 3 rheumatoid arthritis program evaluates more than 4,900 patients with moderate to severe rheumatoid arthritis in six studies, five of which support regulatory submission for upadacitinib. The studies include assessments of efficacy, safety and tolerability across a broad range of rheumatoid arthritis patients. Key measures of efficacy evaluated include ACR responses, Disease Activity Score (DAS28-CRP) and inhibition of radiographic progression.
The U.S. National Domestic Violence Hotline had its busiest year ever in 2018, receiving 573,670 calls, texts and online chats, a 36% increase from 2017.
ReplyDeleteFactors in the rise include increased awareness due to the #MeToo movement that began 2017, and allegations of domestic violence against high-profile people such as as R&B singer R. Kelly and former White House staff security Rob Porter, hotline CEO Katie Ray-Jones told NBC News.
Both men have denied the allegations.
"I wouldn't necessarily say that there's more domestic violence happening," Ray-Jones told NBC News. "I think what is happening is, there's a lot of discourse around the complexities around domestic violence now."
Since 1996, the hotline has provided 24-hour, year-round support for people affected by domestic violence.
In 2018, 88% of people who contacted the hotline reported some form of emotional and verbal abuse, 60% said they were victims of physical abuse, 24% said they were experiencing financial abuse, 15% reported digital abuse such as constant texting, GPS stalking, and unauthorized home surveillance, and 11% said they were victims of sexual abuse, NBC News reported.
One caller was Laura White, 60, of Austin, Texas. She contacted the hotline in September 2010, a year after her husband shot her in the abdomen. Even though her husband was in jail and eventually sentenced to life in prison, White lived in constant fear for her safety.
When she called the hotline, the person who answered let her talk for "two hours totally uninterrupted" and then provided a range of resources, including counseling services through a local women's center and a therapist who could help prepare White to testify against her husband, White said.
"They told me: 'Hey, if you try these and they don't work, call us back. If you try these and they do work, call us back. We are here for you,'" she told NBC News. "Just to have somebody to listen who kept saying 'I know how you feel, I understand,' that was amazing -- worth so much."