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Best Read Drug Approvals Stories in 2022
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.
FDA Approves Rapid-Acting Auvelity for Major Depression
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.
FDA Extends Mirena IUD for Eight Years of Use
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.
FDA Approves First Generic of Symbicort for Asthma and COPD
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.
FDA Approves Mavacamten for Hypertrophic Cardiomyopathy
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.
FDA Expands Imbruvica for Young Children with GVHD
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.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
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In this episode of the "Meet the Board" podcast series, Briana Contreras, Managed Healthcare Executive editor, speaks with Ateev Mehrotra, a member of the MHE editorial advisory board and a professor of healthcare policy and medicine at Harvard Medical School. Mehtrotra is also a hospitalist at the Beth Israel Deaconess Medical Center in Boston. In the discussion, Contreras gets to know Mehrotra more on a personal level and picks his brain on some of his research interests including telehealth, alternative payment models and price transparency.
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FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
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