The FDA has approved a new human parathyroid hormone analog for the treatment of postmenopausal osteoporosis. Abaloparatide is a once-a-day subcutaneous injection similar to teriparatide. It is indicated for postmenopausal women who are at high risk of fracture (previous osteoporotic fracture, multiple risk factors for fracture, or have failed or are intolerant of other therapies). Approval was based on the results of the ACTIVE trial, which showed a relative risk reduction of 86% in new vertebral fractures and 43% in nonvertebral fractures over 18 months (absolute risk reduction of 3.6% and 2.0%, respectively). Similar to teriparatide, abaloparatide carries a warning about a potentially increased risk for osteosarcoma. The drug will be marketed under the trade name Tymlos.
The FDA has approved a generic version of ezetimibe/simvastatin (Vytorin) for the treatment of hypercholesterolemia. Simvastatin lost patent protection in 2006, and ezetimibe’s patent expired in late April. At least two generic manufacturers have filed with the FDA to begin marketing the combination immediately.
The FDA has approved a second biosimilar to infliximab (Remicade), the popular TNF inhibitor used to treat several diseases, including rheumatoid arthritis, ulcerative colitis, and Crohn’s disease. Under the FDA’s naming convention for biosimilars, the new drug is called infliximab-abda and will be marketed as Renflexis. It is expected to be available later this year.
After almost two years of deliberation, the FDA is restricting the use of codeine and tramadol in children < 12 years of age. Codeine is approved to treat pain and cough, and tramadol is approved to treat pain in children, but both drugs carry significant risks, including breathing problems that have led to a reported 24 codeine-related deaths and three tramadol-related deaths. The FDA is requiring labeling changes that indicate codeine should not be used to treat pain or cough and tramadol should not be used to treat pain in children < 12 years of age. Further, tramadol should not be used in children < 18 years of age to treat pain after tonsil and/or adenoid surgery. Codeine and tramadol should not be used in adolescents 12-18 years of age who are obese or have breathing issues such as obstructive sleep apnea or severe lung disease. Finally, codeine or tramadol should not be taken by a mother who is breastfeeding.
The FDA has approved valbenazine to treat tardive dyskinesia, the first drug approved for this indication. Valbenazine is a monoamine transporter 2-inhibitor that is indicated for adults with tardive dyskinesia. It is also under investigation as a treatment for Tourette’s syndrome. Approval was based on a trial of 234 patients. After six weeks, those who received valbenazine demonstrated improvement in the severity of abnormal involuntary movements compared to those who received placebo. The drug may cause sedation and QT prolongation. Valbenazine will be marketed as Ingrezza.
In this section: The agency approves new treatment for postmenopausal osteoporosis, greenlights generic treatment for hypercholesterolemia, give approval to a second biosimilar to infliximab, restricts the use of codeine and tramadol in children, and allows valbenazine to treat tardive dyskinesia.
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content