AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced positive top-line results from the Phase 3 SELECT-PsA 1 clinical trial. In this study, both doses of RINVOQ (upadacitinib; 15 mg and 30 mg, once daily) met the primary endpoint of ACR20 response at week 12 versus placebo in adult patients with active psoriatic arthritis who have responded inadequately or are intolerant to one or more non-biologic disease modifying anti-rheumatic drugs (DMARDs). RINVOQ also demonstrated significant improvements in signs and symptoms of the disease across a variety of endpoints compared to placebo. RINVOQ, a selective and reversible JAK inhibitor discovered and developed by AbbVie, is being studied as a once-daily therapy in psoriatic arthritis and multiple immune-mediated inflammatory diseases.
Ubrelvy is an oral calcitonin gene-related peptide receptor antagonist now approved for the treatment of acute migraines, an FDA press announcement reported. The grant was awarded to Allergan USA, Inc. In clinical trials conducted on over 1,400, the medication was found to be effective in the quick treatment of migraine.
“We believe the approval of DAYVIGO is particularly exciting because it is the first FDA-approved medication to report safety data over a 12-month period along with sleep onset and sleep maintenance efficacy data over a six-month period in a pivotal clinical study,” said Lynn Kramer, MD, Chief Clinical Officer, Neurology Business Group, Eisai in a press statement. “We look forward to making this new therapeutic option available to the millions of patients who suffer with insomnia.”
Health data management company Seqster said this week that it has received a strategic investment of undisclosed size from Takeda Pharmaceuticals of Japan. Seqster, a software-as-a-service firm based in San Diego, plans to use the new funds to accelerate the adoption of its interoperability technology for enhancing clinical trials, patient engagement, and outcomes.