Amgen's Blockbuster Osteoporosis Drug Prolia Flagged With FDA Strictest Warning
Portfolio Pulse from Vandana Singh
The FDA has issued its strictest warning for Amgen Inc's osteoporosis drug Prolia, highlighting the risk of severe low calcium levels in patients with advanced chronic kidney disease. Prolia, a significant revenue generator with $986 million in Q3 sales, now faces market challenges as it approaches US patent expiration in February next year. The warning follows a review of 25 cases from 2010 to 2021. Competing drugs from Merck & Co and Amgen's own portfolio also carry safety warnings for patients with kidney disease.
January 19, 2024 | 6:29 pm
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Amgen's Prolia has received the FDA's strictest warning, which could negatively impact its market performance and stock price, especially as it nears patent expiration.
The FDA's boxed warning is likely to dampen physician enthusiasm for prescribing Prolia, potentially reducing sales. The nearing patent expiration also suggests increased competition and generic entries, which could further impact Amgen's revenue from Prolia.
CONFIDENCE 85
IMPORTANCE 80
RELEVANCE 90
NEUTRAL IMPACT
Merck's Fosamax is mentioned as a competing drug that also carries safety warnings for patients with kidney disease, which may influence its market position in light of the new FDA warning on Amgen's Prolia.
While the news is primarily about Amgen's Prolia, the mention of Merck's Fosamax indicates that it is part of a class of drugs with similar risks. The impact on Merck is less direct, but changes in the competitive landscape could have a neutral to slightly negative effect on Fosamax's market share.
CONFIDENCE 75
IMPORTANCE 40
RELEVANCE 50