Vanda Pharmaceuticals
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- -
- Employees
- 203
- Market Cap
- $311.8M
- Introduction
Vanda Pharmaceuticals, Inc. engages in the development and commercialization of therapies for high unmet medical needs. The firm intends to treat schizophrenia, jet lag disorder, atopic dermatitis, central nervous system disorders, and circadian rhythm sleep disorder. Its product portfolio includes HETLIOZ, Fanapt, Tradipitant, Trichostatin, and AQW051. The company was founded by Mihael Hristos Polymeropoulos and Argeris N. Karabelas in 2002 and is headquartered in Washington, DC.
Vanda's tradipitant fails to secure FDA approval for gastroparesis
FDA declined Vanda Pharmaceuticals' NDA for tradipitant to treat gastroparesis symptoms, despite evidence from studies and patient experience. Vanda plans to pursue marketing authorization and file another NDA for motion sickness prevention.
FDA declines approval for Vanda's gastroparesis treatment
The FDA declined Vanda Pharmaceuticals' NDA for tradipitant to treat gastroparesis, citing insufficient evidence and suggesting further studies. Vanda argues the FDA's decision was delayed and inconsistent with expert advice, while patients have filed a citizen petition urging approval. Vanda remains committed to pursuing marketing authorization and supporting its expanded access program.
FDA Rejects NK1R Antagonist for Gastroparesis
FDA declined to approve tradipitant for gastroparesis, citing need for additional studies. Vanda Pharmaceuticals criticized the decision, noting a positive phase II trial and mixed results from a phase III trial. Tradipitant remains investigational, with other NK1R antagonists approved for chemotherapy-induced nausea and vomiting.
US FDA declines to approve Vanda's stomach condition drug
Vanda Pharmaceuticals' drug tradipitant, intended for gastroparesis, faced FDA rejection, prompting a 14% share drop. The FDA called for additional studies, citing inconsistent design with expert advice. Vanda plans to pursue approval despite FDA's refusal to convene a panel review. Tradipitant, licensed from Eli Lilly, failed to meet nausea severity goals in a late-stage trial and requires further animal studies and long-term safety data.
FDA Declines to Approve Vanda's Marketing Application for Tradipitant in Gastroparesis
FDA declines Vanda's tradipitant NDA for gastroparesis, citing need for additional studies despite evidence of efficacy. Vanda plans to pursue marketing authorization and submit an NDA for motion sickness prevention.
Vanda Contests FDA Rejection of Gastroparesis Drug, Slams 'Delayed' Decision
The FDA denied Vanda Pharmaceuticals’ application for tradipitant, an NK-1R antagonist for gastroparesis, citing a need for additional studies. Vanda criticized the FDA's decision, arguing the agency disregarded evidence and delayed the verdict. The company plans to continue seeking approval and is working on a separate application for tradipitant to prevent motion sickness-induced vomiting.
FDA Issues CRL to Vanda Pharmaceuticals' Tradipitant for Gastroparesis Treatment
FDA declined Vanda Pharmaceuticals' NDA for tradipitant in gastroparesis treatment, citing need for additional studies. Vanda criticized the decision, noting delays and lack of FDA advisory committee review. Tradipitant showed efficacy in reducing nausea in clinical trials, with plans for further submissions and continued support for its expanded access program.
FDA Declines to Approve Vanda's Marketing Application for Tradipitant to Treat Gastroparesis
Vanda Pharmaceuticals Inc. announced the FDA declined approval for tradipitant to treat gastroparesis, citing insufficient evidence despite Vanda's submission of two placebo-controlled studies and real-world data. Vanda disputes the FDA's decision, plans to continue pursuing approval, and supports an expanded access program for patients. A separate NDA for tradipitant for motion sickness is planned.
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