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Best Read FDA Approval Stories in 2023
FDA Approves First Anti-inflammatory Drug for Cardiovascular Disease
In June 2023, the FDA approved Lodoco to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adult patients. Lodoco is the first drug approved to target inflammation that is an underlying cause of atherosclerotic cardiovascular disease.
FDA Approves Pfizer’s Alopecia Drug
The FDA in June 2023 approved Pfizer’s Litfulo (ritlecitinib), a once-daily oral treatment, for people 12 years of age and older with severe alopecia. It has an annual list price of Litfulo is $49,000.
FDA Approves First Drug for Geographic Atrophy Due to AMD
The FDA approved Syfovre in February 2023 with a list price of $2,190 per vial,
New Pediatric Growth Hormone Therapy Costs $8,300 Monthly
Ngenla (somatrogon-ghla), approved by the FDA in June 2023 is a once-weekly, human growth hormone analog for pediatric patients 3 years and older who have growth failure due to inadequate secretion of endogenous growth hormone.
FDA Approves Xdemvy for Eye Infection Caused by Mites
Xdemvy, approved in July, is the first treatment that directly targets the mites involved in the Demodex blepharitis. It has list price of $1,850 per prescription.
GSK’s Arexvy is First RSV Vaccine Approved for Older Adults
Approved in May, Arexvy prevents lower respiratory tract disease (LRTD) caused by RSV in individuals 60 years of age and older.
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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