Paliperidone

Luye Pharma Launches ERZOFRI: Single-Dose Initiation Long-Acting Injectable for Schizophrenia Treatment

2 months ago

• Luye Pharma's ERZOFRI (paliperidone palmitate) extended-release injectable suspension is now commercially available in the U.S. for treating adults with schizophrenia and schizoaffective disorder. • ERZOFRI simplifies treatment with a unique single-dose initiation regimen (351 mg), eliminating the need for a second initiation dose required by currently available monthly paliperidone palmitate injections. • Clinical studies demonstrated bioequivalence to existing paliperidone palmitate treatments with comparable drug exposure and safety profile, potentially improving medication adherence for patients with serious psychiatric disorders.

Johnson & Johnson to Acquire Intra-Cellular Therapies for $14.6 Billion, Bolstering Neuroscience Portfolio

4 months ago

• Johnson & Johnson (J&J) will acquire Intra-Cellular Therapies for $14.6 billion, gaining access to Caplyta and a pipeline of CNS disorder treatments. • Caplyta, approved for schizophrenia and bipolar depression, has a supplemental NDA under FDA review for major depressive disorder (MDD) as adjunctive therapy. • The acquisition includes ITI-1284, a Phase II asset targeting generalized anxiety disorder (GAD) and Alzheimer's-related psychosis, expanding J&J's pipeline. • The deal is expected to close in late 2025, pending regulatory approval, and aims to strengthen J&J's position in neuropsychiatric and neurodegenerative disorders.

Teva's Long-Acting Schizophrenia Drug Rejected by FDA

4 months ago

The FDA has declined to approve Teva's long-acting formulation of schizophrenia drug risperidone, dealing a blow to the company's turnaround efforts. Despite positive phase 3 trial results, the reasons for the rejection remain undisclosed, with Teva and partner MedinCell planning to address the FDA's concerns.

Schizophrenia Market Set for Strong Growth, Driven by Novel Therapies

4 months ago

• The schizophrenia market is expected to grow significantly, driven by the launch of novel therapies and increased diagnosis rates. • Long-acting injectables (LAIs) are gaining traction despite higher costs, offering an alternative to oral antipsychotics. • The US dominates the schizophrenia market due to a large patient population and high drug costs. • Emerging treatments like Cobenfy, evenamide, Ingrezza, and iclepertin aim to address unmet needs in managing both positive and negative symptoms.

CHMP Rejects Neuraxpharm and Apellis Drugs, Companies to Appeal

5 months ago

The EMA's human medicines committee has refused marketing approvals for drugs from Neuraxpharm and Apellis, citing lack of clinically meaningful benefits and concerns over tolerability. Both companies plan to appeal the decisions.

Innovative Therapies for Schizophrenia, Atopic Dermatitis, Hepatitis B, and SLE Highlighted at CIIE

7 months ago

• Johnson & Johnson launched INVEGA HAFYERA in China, a twice-yearly injection for schizophrenia treatment, marking its debut after being introduced at CIIE 2022. • Pfizer showcased Cibinqo and Staquis as innovative therapies for atopic dermatitis (AD), addressing a common immuno-inflammatory disease affecting millions in China. • GSK's Bepirovirsen, a potential 'functional cure' for chronic hepatitis B, is undergoing Phase III clinical studies and has received breakthrough therapy designation in China. • GSK also presented its innovative therapy for systemic lupus erythematosus (SLE) and initiated a public welfare project to improve SLE diagnosis, treatment, and patient support.

Alembic and Zydus Secure USFDA Approvals for Paliperidone and Diltiazem Generics

8 months ago

• Alembic Pharmaceuticals gains USFDA approval for Paliperidone Extended-Release Tablets, a generic version of Invega, used in treating schizophrenia and schizoaffective disorder. • Zydus Lifesciences receives USFDA approval for its generic Paliperidone extended-release tablets, indicated for schizophrenia and schizoaffective disorder treatments. • Alembic Pharma also secures USFDA approval for Diltiazem Hydrochloride Extended-Release Capsules, a generic equivalent to Dilacor XR, used for hypertension and chronic stable angina.

FDA Approves Erzofri (Paliperidone Palmitate) for Schizophrenia and Schizoaffective Disorder

10 months ago

• The FDA has approved Erzofri (paliperidone palmitate) as a monthly injectable for treating schizophrenia and schizoaffective disorder in adults. • Erzofri is the first paliperidone palmitate long-acting injection developed in China to receive U.S. approval, offering a new treatment option. • Approval was based on a study demonstrating bioequivalence to Invega Sustenna, with a comparable safety profile and optimized initial dosing. • Paliperidone palmitate long-acting injections had sales of $2.897 billion in the U.S. in 2023, highlighting the market for this treatment.

Real-World Evidence Gains Momentum: FDA Approvals and Cross-Industry Collaborations Mark Turning Point

5 years ago

• The FDA's approval of Ibrance's expanded indication for male breast cancer patients, supported by real-world evidence, marks a significant milestone in RWE adoption in regulatory decision-making. • Cross-industry collaboration through the Friends of Cancer Research study demonstrated consistency between real-world endpoints and clinical trial outcomes in lung cancer research. • Industry experts predict a 30-50% increase in regulatory decisions incorporating RWE in 2020, with particular focus on single-arm trials using real-world data as comparator cohorts.

Drug Development Updates