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FDA Raises Concerns on Merck's Chronic Cough Drug Gefapixant

Source - reuters.com The U.S. Food and Drug Administration (FDA) has asked Merck to provide more information about the safety risks of its c...

Source - reuters.com
The U.S. Food and Drug Administration (FDA) has asked Merck to provide more information about the safety risks of its chronic cough drug gefapixant before it will approve it for sale. The FDA has expressed concerns about the drug's potential to cause serious side effects, including liver damage and suicidal thoughts.

Background

Gefapixant is an investigational drug that works by blocking a receptor in the brain that is thought to be involved in coughing. Merck submitted a New Drug Application (NDA) to the FDA in January 2022 seeking approval for gefapixant to treat refractory chronic cough.

FDA Concerns

In a letter to Merck, the FDA stated that it had concerns about the following:

The potential for gefapixant to cause liver damage. In clinical trials, some patients who took gefapixant experienced elevated liver enzymes, which is a sign of liver damage.
The potential for gefapixant to cause suicidal thoughts. In clinical trials, there were more reports of suicidal thoughts and behaviors in patients who took gefapixant than in patients who took a placebo.
The FDA has asked Merck to provide more information about the potential risks of gefapixant before it will approve the drug for sale. Merck is currently reviewing the FDA's concerns and is expected to respond to the agency in the coming weeks.

Impact on Patients

The FDA's decision to delay approval of gefapixant is a setback for patients with refractory chronic cough. There are currently no approved treatments for this condition, and patients are often left to manage their symptoms with over-the-counter cough suppressants or other medications that may not be effective.

Next Steps

Merck is expected to respond to the FDA's concerns in the coming weeks. If the FDA is satisfied with Merck's response, it could approve gefapixant for sale. However, if the FDA has any remaining concerns, it could ask Merck to conduct further studies or make changes to its application.

Conclusion

The FDA's decision to delay approval of gefapixant is a reminder of the importance of carefully evaluating the safety and efficacy of new drugs before they are approved for sale. Patients with refractory chronic cough should continue to work with their doctors to manage their symptoms and should be aware of the potential risks of gefapixant if it is ultimately approved for sale.

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