FDA approvals you might have missed
A look at 5 recent approvals from the US Food and Drug Administration (FDA), including treatment for systemic lupus erythematosus, a new gene therapy, and pain relief for patients with irritable bowel syndrome.
The US Food and Drug Administration (FDA) has approved dalteparin sodium (FRAGMIN, Pfizer, Inc.) for patients aged 1 month and older. The drug is the first FDA-approved treatment for venous thromboembolism(VTE) in pediatric patients. It is give subcutaneously twice daily, up to 3 months.
The FDA has approved gene therapy Zolgensma (onasemnogene abeparvovec-xioi, Novartis) for treating children aged younger than 2 years with spinal muscular atrophy (SMA). Zolgensma provides a functional copy of the survival motor neuron (SMN) gene. The SMN gene is mutated in SMA patients.
The FDA has approved belimumab (Benlysta, GlaxoSmithKline) for patients aged 5 years and older with systemic lupus erythematosus (SLE) via intravenous infusion. This is the first drug approval for treating SLE in pediatric patients. Belimumab is a B-lymphocyte stimulator-specific inhibitor.
Glecaprevir and pibrentasvir (Mavyret, AbbVie, Inc.) has been approved by the FDA for treating hepatitis C virus (HCV) in children aged 12 to 17 years. The drug prevents HCV from multiplying and may cure an infection. It should not be used by patients who also take atazanavir and rifampin.
The FDA has allowed marketing for IB-Stim (Innovating Health Solutions), using the 510(k) premarket process. The device is an electrical nerve stimulator that stimulates certain cranial nerves, which is thought to relieve functional abdominal pain linked to irritable bowel syndrome (IBS).