Amgen's Blockbuster Osteoporosis Drug Prolia Flagged With FDA Strictest Warning

The FDA has added a serious warning to the prescribing information for Amgen Inc’s AMGN drug Prolia (denosumab), emphasizing an increased risk of severely low calcium levels in specific patient groups. 

Amgen’s Prolia, initially approved in 2010 for treating bone loss in postmenopausal women and later sanctioned for use in men and women at high risk of fracture, has generated substantial sales, amounting to $986 million in the third quarter. 

Reuters noted that the boxed warning, the strictest cautionary measure issued by the FDA, was implemented following a 2022 review into the risk of very low blood calcium in patients with advanced chronic kidney disease, particularly those undergoing dialysis while using Prolia.

During the investigation, the FDA scrutinized 25 cases spanning from July 2010 to May 2021, underscoring the gravity of the potential side effects associated with the drug. 

Also Read: Full Approval For Amgen’s Flagship Cancer Drug Lumakras Pushed For Around Four Years.

However, as the drug faces the impending loss of its U.S. patent in February next year, the newly issued FDA warning adds a layer of complexity to its market outlook.

Several other medications addressing bone loss or osteoporosis, such as Merck & Co Inc’s MRK Fosamax, Amgen’s Xgeva, and Evenity, already carry safety information, cautioning against prescribing them to patients with kidney disease. 

Given that kidney disease inherently leads to low calcium levels, these drugs pose a potential threat of death or severe injury to affected patients.

Read Next: FDA AdCom Gives Thumbs Down To Late-Stage Data For Amgen’s Lumakras In Advanced Form Of Lung Cancer.

Price Action: AMGN shares are down 0.70% at $306.63 on the last check Friday.

Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.

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