Pediatric News

HAGEMANN APPOINTED TO WHO COMMITTEE

Tracy M. Hagemann, PharmD, professor and associate dean for the University of Tennessee College of Pharmacy has been appointed to serve on a World Health Organization (WHO) committee. Dr. Hagemann will be an external reviewer for a guideline being developed for managing chronic pain in children. It is being developed through the WHO's Maternal, Newborn, Child, and Adolescent Health and Ageing division. Dr. Hagemann is one of the only three members of this group from the United States and is the only pharmacist selected. Dr Hagemann is a member of the JPPT Editorial Board and is a fellow in PPA.

REED RECEIVES ACCP DISTINGUISHED INVESTIGATOR AWARD

Michael D. Reed, PharmD, FCCP, FCP received the 2020 Distinguished Investigator award from the American College of Clinical Pharmacology on September 22, 2020. The award is given annually and is intended to recognize superior scientific expertise and accomplishments by a senior investigator, usually involving a distinct area of research in basic or clinical pharmacology for which the individual is internationally known. Dr. Reed, Emeritus Professor of Pediatrics, School of medicine, Case Western Reserve University is a member of PPA and an associate editor of the JPPT. Dr Reed also received the 2010 Sumner J. Yaffe Lifetime Achievement Award in Pediatric Pharmacology and Therapeutics from PPA.

FDA APPROVES SIMPONI ARIA (GOLIMUMAB)

The Food and Drug Administration approved efficacy supplements for Simponi Aria for patients ≥2 years of age for the treatment of active psoriatic arthritis or active polyarticular juvenile idiopathic arthritis. The approved recommended dosage for pediatric patients is 80 mg/m² intravenous infusion over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter.

The FDA based its approval on results from the phase 3 GO-VIVA trial, a 52-week open-label study among children with JIA (n=127) with active polyarthritis aged 2 to 17 years who had active arthritis in five or more joints, despite receiving treatment with methotrexate for at least 2 months. The trial was conducted as a post-marketing requirement under the Pediatric Research Equity Act after the FDA approval of Simponi Aria for adults with moderately to severely active rheumatoid arthritis in 2013. According to study results, pharmacokinetic exposure of golimumab in pediatric patients was consistent with that of two pivotal phase 3 clinical trials of golimumab in adult patients with moderately to severely active polyarticular juvenile idiopathic arthritis and active psoriatic arthritis. Additionally, researchers found that the efficacy was largely consistent with responses in adult patients with RA.

Golimumab Injection is a sterile solution of the golimumab antibody supplied in a 4-mL glass vial for intravenous infusion. It is a preservative-free, colorless to light yellow solution with a pH of approximately 5.5. It is not made with natural rubber latex. Each 4-mL vial contains 50 mg golimumab, L-histidine, polysorbate 80 (0.6 mg), sorbitol (180 mg), and water for injection. Simponi Aria must be refrigerated at 2° C to 8° C and protected from light until the time of use.