Setback for Vanda as FDA denies approval for insomnia treatment
- FDA rejects Vanda Pharmaceuticals’ request for expanded approval of Hetlioz
- Hetlioz will not be approved to treat insomnia characterized by difficulties with sleep initiation
- Vanda Pharmaceuticals received a complete response letter from the FDA
- The company is reviewing the letter and considering its next steps
- 2023 Hetlioz net product sales decreased by 37% compared to 2022
The U.S. Food and Drug Administration has officially turned away a request from Vanda Pharmaceuticals for expanded approval of its sleep-disorder drug Hetlioz to treat insomnia characterized by difficulties with sleep initiation. Vanda on Wednesday said the FDA issued a complete response letter, indicating the agency won’t approve the application in its current form. Vanda last month had warned that the FDA, which previously assigned a March 4 target action date for the application, had notified the Washington-based company that it had identified deficiencies that precluded discussion of labeling and post-marketing requirements/commitments. Vanda on Wednesday said it is reviewing the FDA letter and evaluating its next steps. The company reported 2023 Hetlioz net product sales of $100.2 million, a 37% decrease from 2022.
Factuality Level: 9
Factuality Justification: The article provides a straightforward report on the FDA’s decision to turn down Vanda Pharmaceuticals’ request for expanded approval of its sleep-disorder drug. It sticks to the facts without including any irrelevant information, bias, or sensationalism. The information is clear and concise, focusing on the key points of the FDA’s response and Vanda’s next steps.
Noise Level: 3
Noise Justification: The article provides relevant information about the FDA’s decision to turn down Vanda Pharmaceuticals’ request for expanded approval of its sleep-disorder drug. It includes details about the complete response letter, the company’s response, and the decrease in net product sales. However, the article lacks in-depth analysis, antifragility considerations, and accountability of powerful people. It stays on topic and supports its claims with specific examples.
Financial Relevance: Yes
Financial Markets Impacted: The financial markets impacted by this news article are the pharmaceutical industry and Vanda Pharmaceuticals.
Presence Of Extreme Event: No
Nature Of Extreme Event: No
Impact Rating Of The Extreme Event: No
Rating Justification: The news article pertains to the FDA’s decision to reject Vanda Pharmaceuticals’ request for expanded approval of its sleep-disorder drug. While this decision has financial implications for Vanda Pharmaceuticals, there is no mention of an extreme event or its impact rating in the article.
Public Companies: Vanda Pharmaceuticals (VNDA)
Key People: Colin Kellaher (Author)
Reported publicly:
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