Pediatric Indication Expanded for Evkeeza
Regeneron received expanded approval from the U.S. Food and Drug Administration (FDA) on March 21, 2023, to widen the indication for Evkeeza™ (evinacumab-dgnb) injection to include children as young as five years old. The only presently approved drug in its therapy class, angiopoietin-like 3 (ANGPTL3) inhibitors, Evkeeza is used along with other cholesterol-lowering drugs to treat patients who have homozygous familial hypercholesterolemia (HoFH). Affecting around 1,300 patients in the U.S., HoFH occurs when both parents pass to a child defects in specific genes that affect the ways that lipids are metabolized. It causes very high cholesterol levels that can result in serious cardiovascular (CV) problems, including heart attacks, at very young ages. Given by intravenous (IV) infusions, Evkeeza is dosed at 15mg/kg of body weight once each month. For its revised prescribing information, look here.
New Formulation Approved for Hyrimoz
The FDA approved a 100mg/mL, citrate-free version of Hyrimoz® (adalimumab-adaz) on March 20, 2023. Sandoz’s biosimilar to the citrate-free version of AbbVie’s Humira (adalimumab), is a monoclonal antibody that inhibits tumor necrosis factor (TNF), to reduce inflammation. Its indications are the same as Humira’s (with the exceptions of hidradenitis suppurativa and uveitis) — for treating adults who have ankylosing spondylitis (AS), plaque psoriasis, psoriatic arthritis (PsA), rheumatoid arthritis (RA) or ulcerative colitis (UC); for treating children at least two years of age who have polyarticular juvenile idiopathic arthritis (JIA); and for treating patients aged six years and older for Crohn’s disease. It is given by subcutaneous (SC) injections — usually once every two weeks — through prefilled syringes and auto-injector devices. For many of its adult indications, the recommended maintenance doses are 40mg, after higher loading doses. Pediatric dosing is based on the child’s weight. A boxed warning on the labels of all TNF blockers and information in Medication Guides for patients describes the increased risks of cancer and serious infections that may be associated with their use. Prospective patients should be screened for tuberculosis (TB) before starting treatment and periodically while therapy continues. The provisions of a settlement agreement will allow Hyrimoz to be released on July 1, 2023. It cannot be interchanged with Humira or any other Humira biosimilar. Here is its updated prescribing information.
Through the Consumer Product Safety Commission (CPSC) some 5gm tubes of lidocaine/prilocaine cream were recalled by Sandoz on March 9, 2023. Although the topical anesthetics are intended for use within institutions, some tubes unintentionally were dispensed through retail pharmacies. They are not child-resistant, raising the potential for accidental poisoning. Adverse effects from swallowing large quantities of the cream could include cardiovascular (CV) effects such as slow heartbeats and low blood pressure; and central nervous system (CNS) effects such as dizziness and seizures. Additionally, the tubes are very small – presenting a choking hazard if swallowed. For details on the recall, notices are here from CPSC and here from Sandoz.
On March 15, 2023, Camber Pharmaceuticals recalled one lot of their atovaquone oral suspension. It may be contaminated with Bacillus cereus bacteria, which Camber believes have “. . . reasonable probability that . . . can result in. . .life threatening infections such as endocarditis and necrotizing soft tissue infections.” Atovaquone is used to treat immunocompromised patients who are more susceptible to infections. More information is here.