Novo Nordisk has decided to permanently discontinue the manufacturing and distributing of all formulations of Levemir® (insulin detemir) and GlucaGen® HypoKit® in the U.S. market. Contributed factors to the Levemir®discontinuation decision includes global manufacturing constraints, significant formulary losses impacting…
On November 8, 2023, the U.S. Food and Drug Administration (FDA) approved Zepbound™ (tirzepatide) injection for chronic weight management in adults. Tirzepatide, the active ingredient in Zepbound™, is already approved under the trade name Mounjaro™ to be used in the treatment of type 2 diabetes mellitus. In clinical trials, patients that received the highest dose of Zepbound™ experienced an average weight loss of 20.9%. Novo Nordisk’s Wegovy® (semaglutide) was studied in a similar population and patients experienced an average weight loss of 14.9% at the recommended maintenance dose. Lilly has announced that Zepbound™ will be available in the United States by the end of 2023 with an estimated annual cost of $13,778, which is approximately 20% less than the annual WAC of Wegovy®. People who are commercially insured without coverage for Zepbound™ may be eligible to pay as low as $550 for a 1-month prescription of Zepbound™, approximately 50% lower than the list price, a similar savings program for Wegovy® lowers out-of-pocket cost for patients without coverage to approximately $1,119.
On October 31, 2023, the U.S. Food and Drug Administration (FDA) approved Wezlana™ (ustekinumab-auub) injection manufactured by Amgen. This is the first approved biosimilar to Stelara® (ustekinumab) injection manufactured by Janssen Biotech – Wezlana™ is also interchangeable. In states where pharmacy regulations allow substitution, it can be dispensed instead of Stelara® without contacting the prescriber. Ustekinumab is used to treat adults who have active Crohn’s disease (CD) or ulcerative colitis (UC), psoriatic arthritis (PsA) or plaque psoriasis. Under a settlement agreement, Wezlana™ can be launched in the U.S. at any time before January 1, 2025. Additional biosimilars to Stelara® are expected to launch in 2025. U.S. sales for Stelara® amounted to approximately $6.4 billion in 2022.
On March 14, 2023, Novo Nordisk announced price cuts to several prefilled insulin pens and vials, which will be effective starting on January 1, 2024. Outlined below…
On August 25, 2023, several generic drug manufacturers received U.S. Food and Drug Administration (FDA) approval for A-rated generics to Vyvanse® (lisdexamfetamine – Takeda Pharmaceuticals). Lisdexamfetamine is taken once each morning to treat attention deficit hyperactivity disorder (ADHD) for patients at least six years old and binge eating disorder (BED) for adults. A boxed warning cautions that lisdexamfetamine is a Class II controlled (CII) central nervous system (CNS) stimulant with increased potential for abuse and/or dependence. Brand Vyvanse® typically costs about $370 per month while generic lisdexamfetamine is expected to cost approximately $160 per month.
https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-multiple-generics-adhd-and-bed-treatment
