At an ACR COVID-19 town hall on COVID-19, infectious disease experts discussed the most up-to-datecurrent information on pre- and post-exposure monoclonal antibody therapy, oral antivirals and vaccines for rheumatology patients.
FDA Authorizes New Long-Acting, Monoclonal Antibodies for Pre-exposure Prevention of COVID-19 in Certain Individuals
On Dec. 8, the U.S. Food & Drug Administration (FDA) issued an emergency use authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms [about 88 pounds]). The product…
The Race Is On: Clinical Trials Begin for Agents Biosimilar to Denosumab
As the U.S. and other patents for branded denosumab products get closer to expiring, drug manufacturers are initiating clinical trials for more affordable, biosimilar versions of the treatment.
Osteoarthritis Treatments: Monoclonal Antibody Starts Clinical Trial & Fasinumab Promising for Treating Pain
Recent clinical trials have evaluated the efficacy of GSK3196165, a monoclonal antibody, and fasinumab, a nerve growth factor antibody, in treating patients with osteoarthritis and pain…
Mucosal Healing Seen with Infliximab Biosimilar CT-P13 in Ulcerative Colitis
NEW YORK (Reuters Health)—About two-thirds of patients with ulcerative colitis (UC) had mucosal healing by the end of induction treatment with the infliximab biosimilar CT-P13, according to results of the first prospective study to evaluate this. CT-P13 is the first biosimilar monoclonal antibody of reference infliximab (Remicade) approved in Europe and several other countries where…
Sifalimumab Shows Some Promise Against Lupus
NEW YORK (Reuters Health)—Sifalimumab, an anti-interferon alpha monoclonal antibody, may lead to some improvement in patients with systemic lupus erythematosus (SLE), according to a new trial. In a paper online on March 23 in Annals of the Rheumatic Diseases, Dr. Munther Khamashta of King’s College London and colleagues note that treatment of SLE presents a…
Etanercept Submitted to FDA for Approval to Treat Pediatric Plaque Psoriasis; Boehringer Ingelheim & AbbVie to Collaborate; Low Doses of Gerilimzumab Promising for RA
The FDA has received an application to expand the use of etanercept to treat plaque psoriasis in pediatric patients. Boehringer Ingelheim and AbbVie have announced a collaborative partnership to develop treatments for multiple autoimmune diseases. And gerilimzumab may prove safe and effective for treating inflammatory diseases at very low doses…
Abaloparatide Effective for Osteoporosis & XmAb5871 Studied to Treat SLE
Abaloparatide has completed clinical trials, which showed the treatment to be safe and effective in reducing fracture rates in postmenopausal women with osteoporosis. Also, XmAb5871 is being studied to treat systemic lupus erythematosus and doesn’t destroy B cells…
Amgen, UCB Say Osteoporosis Drug Meets Main Goal in Late-Stage Trial
(Reuters)—Amgen Inc. and Belgium-based UCB SA said on Monday that their osteoporosis drug met all the primary endpoints by reducing the incidence of new vertebral fracture in postmenopausal women with osteoporosis in a late-stage study. The topline results, from a Fracture study in postmenopausal women with osteoporosis (FRAME), showed that the drug romosozumab met a…
FDA Advisory Panel Strongly Backs Biosimilar Form of Remicade
(Reuters)—A medical advisory panel to the U.S. Food and Drug Administration on Tuesday recommended approval of a cheaper biosimilar form of Johnson & Johnson’s arthritis drug Remicade (infliximab) that could eventually batter sales of the branded product. The panel, by a vote of 21-3, supported use of the biosimilar from Celltrion Inc. and Pfizer Inc.,…