Vanda Pharmaceuticals Submits NDA for Novel Antipsychotic Bysanti to Treat Bipolar I Disorder and Schizophrenia
• Vanda Pharmaceuticals has submitted a New Drug Application to the FDA for Bysanti (milsaperidone), seeking approval for the treatment of acute bipolar I disorder and schizophrenia.
• Bysanti is a novel atypical antipsychotic that works by interacting with multiple neurotransmitter receptors including alpha-adrenergic, serotonin, and dopamine receptors in the brain.
• If approved, Bysanti could reach the US market by 2026, with potential patent exclusivity extending into the 2040s, while Phase III trials for its use in major depressive disorder are currently underway.
Vanda Pharmaceuticals Reports Revenue Increase and Advances Pipeline in Q3 2024
• Vanda Pharmaceuticals reported a 23% increase in Q3 2024 revenues, reaching $47.7 million, driven by sales of Fanapt, HETLIOZ, and PONVORY.
• The company is advancing its psychiatry portfolio, with plans to submit an NDA for milsaperidone for schizophrenia and bipolar I disorder in early 2025.
• Vanda initiated the commercial launch of PONVORY for multiple sclerosis and is exploring its use in psoriasis and ulcerative colitis with IND submissions expected in Q4 2024.
• A New Drug Application for tradipitant in motion sickness is expected to be submitted in Q4 2024, building on positive clinical trial results.
Schizophrenia Clinical Trial Pipeline Boasts 60+ Drugs Under Development
• The schizophrenia treatment landscape is expanding with over 60 drugs in active development, driven by increased R&D and innovative therapies.
• Key players like Sumitomo Pharma, Boehringer Ingelheim, and Reviva Pharmaceuticals are advancing novel antipsychotics and personalized medicine approaches.
• Recent progress includes positive Phase III trial results for brilaroxazine and LY03020's IND approval in China, signaling potential new treatment options.
• COBENFY, a first-in-class muscarinic agonist, received FDA approval, marking a significant advancement in schizophrenia treatment after 35 years.
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