The European Medicines Agency has accepted for review Lupin‘s marketing authorization application for YLB113, a biosimilar of etanercept that is marketed by Amgen under the brand name Enbrel. YLB113’s application is for the treatment of ankylosing spondylitis, axial spondyloarthritis, and non-radiographic axial spondyloarthritis, as well as rheumatoid and psoriatic arthritis…
As President Trump signed the recently passed Right to Try legislation into law in a White House ceremony, Jordan McLinn of Indianapolis tried twice to embrace him. The third time, 9-year-old Jordan finally got the hug he wanted — as well as a kiss on the forehead. The video of…
Long-term treatment with Abbvie‘s adalimumab, sold as Humira, led to sustained clinical remission accompanied by better physical abilities in patients with nonradiographic axial spondyloarthritis (nr-axSpA). “Clinical and MRI remission in patients with nonradiographic axial spondyloarthritis who received long-term open-label adalimumab treatment: 3-year results of the ABILITY-1 trial”…
Finding treatments and potential cures for rare diseases is crucial, but so is the quality of patients’ lives — a rather nebulous term that means different things to different people. “Recently, there’s been much more of a focus on Quality of Life (QoL) issues, real-world evidence and patient-reported outcomes,” said…
Cimzia (certolizumab pegol) appears to effectively reduce disease activity and manage disease symptoms in patients with axial spondyloarthritis (axSpA) without X-ray evidence of ankylosing spondylitis, according to Phase 3 trial results. The trial also highlights the limitations of current standard-of-care therapies to deliver adequate disease control.
Mylan and Fujifilm Kyowa Kirin Biologics are partnering to commercialize a biosimilar to Humira (adalimumab) after obtaining European approval. Humira, developed by AbbVie, is a tumor necrosis factor alfa (TNFα)-inhibitor approved in the U.S. and Europe for the treatment of several chronic inflammatory conditions, including ankylosing spondylitis.
The National Organization for Rare Disorders (NORD) will celebrate the 35th anniversary of both the 1983 Orphan Drug Act and NORD’s founding at a dinner tonight in Washington, D.C. The 2018 Rare Impact Awards, to be held at the Andrew W. Mellon Auditorium, will be webcast via Facebook for those…
Ankylosing spondylitis patients receiving secukinumab should be monitored and switched to other options if they begin to develop digestive symptoms, a study suggests. Secukinumab (trade name Cosentyx) is a human anti-interleukin-17 monoclonal antibody that inhibits interleukin 17A, a molecule produced mainly by inflammatory cells of the immune system that promotes inflammation. The U.S. Food and Drug…
The European Union isn’t doing enough to protect the 30 million or so people with rare diseases who live in its 28 member countries, officials meeting last week in Vienna said. More than 900 people from 58 nations attended the 9th European Conference on Rare Diseases & Orphan Drugs (ECRD),…
Ankylosing spondylitis patients who receive tailored, personalized services, such as care coach calls, have a higher probability of achieving controlled disease within six to 18 months, a study shows. The study, “Impact of the Adalimumab Patient Support Program on Clinical Outcomes in Ankylosing Spondylitis: Results from the…
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