Among the top-read FDA approval stories include the fast-acting Auvelity to treat major depressive disorder; an extended use for Mirena IUD; the first generic of Symbicort for asthma; Camzyos, a first-in-class treatment for obstructive hypertrophic cardiomyopathy; and Imbruvica’s expanded indication for children with chronic graft versus host disease.
The FDA has approved Axsome Therapeutics’ Auvelity (dextromethorphan-bupropion) extended-release tablets to treat major depressive disorder (MDD) in adults. Axsome anticipates Auvelity (formerly called AXS-05). Auvelity is the first and only rapid-acting oral medicine approved for the treatment of MDD with significant antidepressant efficacy starting at one week.
The FDA has approved a supplemental new drug application (sNDA) that extends the duration of use of Bayer’s intrauterine device (IUD) Mirena (levonorgestrel-releasing intrauterine system) by one more year, making it available to prevent pregnancy for up to eight years.
The FDA has approved the first generic of AstraZeneca’s Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for two common pulmonary health conditions: asthma in patients six years of age and older; and the maintenance treatment of airflow obstruction and reducing exacerbations for patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
The FDA has approved Bristol Myers Squibb’s Camzyos (mavacamten) for the treatment of adults with obstructive hypertrophic cardiomyopathy (HCM). Camzyos is a first-in-class therapy that addresses the excessive contraction of the heart that leads to severe disease where the blood flow is obstructed. It is thought to work by decreasing the number of actin-myosin cross-bridges, which reduces the heart muscle’s ability to contract. The label of Camzyos includes a boxed warning for the risk of heart failure.
The FDA has approved Imbruvica (ibrutinib) to treat children one year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. This is the first pediatric indication for Imbruvica and the 12th approval for the therapy. Imbruvica is jointly developed and commercialized by Janssen Biotech and Pharmacyclics, an AbbVie company.