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FDA Approves Onivyde with Black Box Warning

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Frank Hoffman2 years ago

Reuters reports that the US Food and Drug Administration (FDA) gave its approval for Merrimack’s new pancreatic cancer drug Onivyde last Thursday. However, with the approval, the drug regulator also issued a severe warning regarding the drug’s side effects.

Onivyde Carries Black Box Warning

Onivyde is a drug developed as an additional treatment to chemotherapy, and is intended for use as an alternative for patients with pancreatic cancer who are not responding to standard treatments.

Though effective, clinical studies suggested the drug can result in serious adverse events including sever diarrhea and low white blood cell count. As a result, the FDA has ordered that the drug carry a ‘black box’ warning addressing these risks.

Despite the warnings, Merrimack is optimistic about the future of the drug and plans to begin marketing it within the next week and has made a licensing agreement with Baxter International Inc. to sell the drug in overseas markets in the future.

Pancreatic Cancer Facts

The following information was provided by the Hirshberg Foundation for Pancreatic Cancer Research:

  • According to the Hirshberg Foundation for Pancreatic Cancer Research, over 48,000 Americans are diagnosed with pancreatic cancer every year.
  • Pancreatic Cancer is the 4th leading cause of cancer related deaths in the United States.
  • 94% of patients diagnosed with pancreatic cancer die within five years of diagnosis.
  • Treatment options for individuals with pancreatic cancer are exceptionally limited, surgery is a viable option for less than 20% of patients. 


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