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Biogen's Avonex to Carry Stronger Warning Label Due to Rare Liver Failure Risk

Strategic Insights

— 2 min read

The US Food and Drug Administration (FDA) and Biogen Idec announced on Wednesday that Avonex, the top-selling multiple sclerosis (MS) treatment, will carry a stronger warning label about its rare risk of causing liver failure. This move comes after a series of setbacks in the MS community, including the withdrawal of Tysabri from the market and the suspension of a clinical trial of a new drug in the same class. Experts speculate that the FDA is taking a cautious approach, but this development may dampen optimism for future MS treatments. Despite this, five other MS drugs, including Avonex, remain available, although their manufacturers may not benefit much due to the similar risks associated with Tysabri-like drugs.

Key Takeaways:

  • The FDA and Biogen Idec have announced that Avonex will carry a stronger warning label due to the rare risk of liver failure.
  • The stronger warning will match the existing warning label on rival drug Rebif.
  • The news marks the latest blow to the MS community, following the withdrawal of Tysabri from the market and the suspension of a clinical trial of a new drug in the same class.
  • USMS Specialist Nicholas LaRocca stated that the withdrawal of Tysabri and the suspension of the Glaxo trial represent a "chink in optimism for the future" of MS treatments.
  • The condition of liver failure associated with Avonex is considered "very, very rare" by Biogen Idec.
  • Five other MS drugs, including Avonex, are still available for patients.
  • Analyst Winton Gibbons notes that the overall risk of liver failure is small, but the label change may have a minor impact on sales.
  • Biogen shares fell 2.3% to $37.19 on Wednesday, which is consideration of the potential impact of the stronger warning label on revenue.
  • MS is a progressive disease of the central nervous system that affects over 400,000 people in the US and over 1 million worldwide.

Statistics:

  • Avonex accounted for $991 million of the total $2.2 billion in MS drug sales in 2004.
  • The 2004 revenue of Avonex for Biogen Idec was $1.4 billion.
  • The overall sales of Avonex in the market.
  • The number of patients undergoing liver failure due to Avonex (Specific figure not provided by Biogen).
  • The estimated number of MS drug trials currently underway in the US, which is over 400 and are widespread across the industry with some not including Tysabri-like drugs.

Sources:

  • US Food and Drug Administration (FDA)
  • Biogen Idec
  • National Multiple Sclerosis Society
  • Nicholas LaRocca, USMS Specialist
  • Winton Gibbons, Biotech Analyst for William Blair
  • William Blair
  • IMS Health
  • Reuters (for the quote on the hope to restart the trial)

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