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Medical updates: FDA designations and pediatric mental health trends
Recent medical developments include the FDA granting Breakthrough Therapy Designation to certolizumab pegol (Cimzia) for preventing adverse pregnancy outcomes in women with antiphospholipid syndrome. Additionally, AbbVie’s atogepant (Qulipta) met primary and secondary endpoints in a phase 3 study, showing a reduction in menstrual migraine days compared to a placebo.
In pediatrics, a study published in the Annals of Emergency Medicine reported a 74% increase in suicide-related emergency department visits among US children between 2016 and 2022. Meanwhile, the FDA granted Priority Review to Genentech’s satralizumab (Enspryng) for treating myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) in patients aged 12 and older, following phase 3 trial results showing a 68% reduction in relapse risk.
Other updates include new guidance from the Society of Family Planning regarding the removal of deep contraceptive implants and recommendations from the American Society of Anesthesiologists regarding anesthesia for external cephalic version in breech presentations.
Entities
AbbVie · Ann & Robert H. Lurie Children's Hospital of Chicago · Genentech · UCB