Among the top safety stories this year are Genentech’s warning to Ocrevus label, FDA’s update to GnRH agonists, a study about JAK-inhibitor side effects, FDA’s warning about Prolia in kidney disease and safety issues related to the potential Alzheimer’s disease drug lecanemab.
Genentech has updated the warnings section on the Ocrevus and added a new subsection about the risk of progressive multifocal leukoencephalopathy, an infection of the brain caused by a virus targets the cells that make myelin. Ocrevus is a monoclonal antibody that treats adult patients with relapsing forms of multiple sclerosis and primary progressive multiple sclerosis. It targets the CD20-positive B immune cell that plays a key role in the disease.
The FDA has implemented a class labeling change for gonadotropin-releasing hormone agonists to warn about the risk of pseudotumor cerebri (also known as idiopathic intracranial hypertension) in children. Gonadotropin-releasing hormone agonists stop the production of estrogen and progesterone. They are used to treat endometriosis, uterine fibroids, precocious puberty and infertility. Some children who have received these therapies have experienced pseudotumor cerebri, which results in elevated spinal fluid pressure in the brain.
The latest trial results show Biogen and Eisai’s investigational Alzheimer’s disease drug lecanemab slowed cognitive in early disease, but safety questions remain. While two deaths have been reported during clinical trials, the manufacturers do not believe the deaths were caused by the medication. It is currently under review by the FDA and a decision is expected by Jan. 6.
The FDA has required boxed warnings on three JAK inhibitors to warn about the risk of heart-related events such as heart attack or stroke, cancer, blood clots. But those adverse events may differ among the three products. Although Xeljanz, Olumiant and Rinvoq are in the same drug class, the risk of serious adverse events from these three products to treat rheumatoid arthritis and other inflammatory conditions may not be similar.
The FDA is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis treated with Amgen’s osteoporosis therapy Prolia. The agency’s review of interim results from an ongoing suggests an increased risk of low calcium levels in the blood in patients with advanced kidney disease. Preliminary results from a separate internal FDA study further investigating hypocalcemia in dialysis patients treated with Prolia show a substantial risk with serious outcomes, including hospitalization and death.