Monthly News Roundup - March 2017
Ocrevus Approved for Novel Use Among Multiple Sclerosis Treatments
The much anticipated multiple sclerosis (MS) treatment Ocrevus (ocrelizumab) was given the green light from the FDA this month. Ocrevus is a humanized monoclonal antibody designed to selectively target CD20-positive B cells. It is the first treatment approved for primary progressive multiple sclerosis (PPMS); it’s also indicated for relapsing (RMS). In both forms of MS, Phase III studies demonstrated that Ocrevus slowed disability progression and reduce signs of disease activity in the brain (MRI lesions). In the RMS group, relapses per year were reduced by nearly one-half. Mild to moderate side effects include infusion reactions and upper respiratory tract infections.
Dupixent Injection Cleared For More Advanced Eczema
Eczema is also known as atopic dermatitis, a chronic inflammatory skin disease resulting in red, scaly, crusty and itchy bumps. This week the FDA cleared Regeneron’s Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema who cannot use or have inadequate results with topical therapies. Dupixent, an interleukin-4 receptor alpha antagonist, can be used with or without topical corticosteroids. Clinical trials evaluating safety and effectiveness of Dupixent in over 2,100 adults with moderate-to-severe atopic dermatitis revealed a greater response, defined as clear or almost clear skin as compared to placebo, with a reduction in itch, after 16 weeks of therapy.
Zejula FDA-Approved for Recurrent Ovarian Cancer in Women
The FDA has approved Zejula (niraparib) for the maintenance treatment of women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer following response to platinum-based chemotherapy. Zejula is an oral, once-daily poly(ADP-ribose) polymerase (PARP) inhibitor, and the first PARP inhibitor that does not require BRCA mutation or other biomarker testing. In pivotal clinical studies in patients with a germline BRCA mutation, the median progression-free survival (PFS) was 21 months, compared to 5.5 months for the control group. In the group without a BRCA mutation, median PFS was 9.3 months compared with 3.9 months in the placebo group.
Kisqali From Novartis Approved to Treat Advanced Breast Cancer
Kisqali (ribociclib) was FDA-approved in March and is a kinase inhibitor (CDK4/6 inhibitor), in the same drug class as Pfizer's Ibrance. Kisqali is used alongside an aromatase inhibitor for the treatment of postmenopausal women with HR+/HER2- metastatic breast cancer. In studies, patients who received Kisqali plus letrozole reduced their risk of disease worsening or death by 44% over letrozole alone, and over half saw their tumors shrink by at least 30%. Common side effects include low white blood cells, upset stomach, hair loss, and fatigue, among others. CYP450 3A4 enzyme interactions and heart monitoring figure prominently in the drug label.
FDA Approves Xadago for “Off” Episodes in Parkinson’s Disease
The FDA has approved Xadago (safinamide) tablets, a dual selective monoamine oxidase inhibitor and glutamate inhibitor for use in Parkinson’s disease. Xadago is indicated as an add-on treatment to levodopa/carbidopa (Sinemet) in patients who experience “off” episodes. An “off” episode occurs when a patient’s levodopa has worn “off”, leading to worsened Parkinson’s disease symptoms such as tremor, stiffness, and difficulty walking. In clinical trials, patients receiving Xadago had more “on” time, meaning their Parkinson’s symptoms were reduced without dyskinesia (involuntary movements), compared to the placebo group. Side effects included uncontrolled involuntary movement, falls, nausea, and trouble sleeping or falling asleep (insomnia).
Posted: March 2017