Vanda Pharmaceuticals

Global gastroparesis drugs market to grow by USD 1.42 billion from 2024-2028, driven by rising diabetes prevalence and emerging market opportunities, despite stringent regulatory challenges. Key players include Abbott Laboratories, AbbVie Inc., and others.

DelveInsight's 'Bipolar Disorder (Manic Depression) Pipeline Insight, 2024' report details 22+ pipeline drugs from 22+ companies, segmented by RoA, MoA, and molecule types, with therapies in various clinical stages, including late-stage candidates like Vanda Pharmaceuticals' Iloperidone.

Tau Inhibitors Clinical Trial Pipeline Analysis shows 25+ key companies expected to transform treatment, with increased funding accelerating advancements in neurodegenerative disease therapies.

Schizophrenia clinical trial pipeline features 55+ companies and 60+ drugs, with key players like Sumitomo Pharma America, Boehringer Ingelheim, and Reviva Pharmaceuticals advancing novel therapies. Recent milestones include Reviva's Phase III RECOVER trial data, Luye Pharma Group's IND approval for LY03020, and Teva's positive SOLARIS trial results. DelveInsight's report provides comprehensive global coverage and insights into the schizophrenia pipeline.

September 2024 FDA updates include approvals for Embecta's tubeless patch pump for diabetes, Travere Therapeutics' sparsentan for IgA nephropathy, Johnson & Johnson's guselkumab for ulcerative colitis, and the first over-the-counter hearing aid software device. Other approvals cover treatments for conditions like chronic rhinosinusitis with nasal polyps, atopic dermatitis, eosinophilic granulomatosis with polyangiitis, Niemann-Pick disease type C, and schizophrenia. The FDA also issued warnings and accepted NDAs for various treatments, including delgocitinib cream for chronic hand eczema and roflumilast foam for psoriasis.

September 2024 saw FDA approval of guselkumab (Tremfya) for ulcerative colitis and a CRL for Vanda Pharmaceuticals’ tradipitant for gastroparesis. Research highlighted treatment dissatisfaction in IBS patients, key bacteria affecting IBD response to thiamine, and FMT delivery methods for IBS. Upper GI mucosal damage was linked to Parkinson disease risk, while MASLD and MetALD increased liver and gastrointestinal cancer risks. The 2024 GHAPP conference featured discussions on medication positioning in Crohn disease and managing gut-brain interaction disorders.

The U.S. FDA approved Bristol Myers Squibb's schizophrenia drug, Cobenfy (KarXT), which reduces symptoms without common side effects, acquired through the $14 billion takeover of Karuna Therapeutics. Expected to generate $2.5 billion in U.S. sales by 2030, it targets cholinergic receptors, unlike traditional dopamine-targeting antipsychotics. Bristol plans to launch the drug in late October at $1,850 per month, with 80% of patients covered by Medicare and Medicaid.

Novo Nordisk shares fell 6% after mixed Phase 2 weight-loss drug results; Sanofi presented data supporting tolebrutinib for MS; Lasker Awards given to scientists for GLP-1 weight-loss drug research; Edgewise Therapeutics' heart failure drug shows promising early results; FDA declines to approve Vanda Pharmaceuticals' gastroparesis drug; House Energy and Commerce Committee supports extending pediatric rare disease voucher program.

Vanda Pharmaceuticals' drug tradipitant, intended to treat gastroparesis, was declined approval by the FDA, prompting a 14% share drop. The FDA requested additional animal studies and long-term safety data, raising concerns about chronic use. Vanda plans to continue pursuing approval despite the FDA's refusal to convene an expert panel.

The FDA declined Vanda Pharmaceuticals' NDA for tradipitant to treat gastroparesis, citing insufficient evidence. Vanda argues the FDA's decision was delayed and inconsistent with expert advice. Patients have filed a citizen petition urging approval, while Vanda plans to pursue marketing authorization and submit an NDA for motion sickness prevention by 2024.