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Supplemental New Drug Applications for Once-Monthly Long-Acting Therapy INVEGA® SUSTENNA® (paliperidone palmitate) Submitted to the U.S. FDA for the Treatment of Schizoaffective Disorder
New submission based on positive data from a 15-month schizoaffective relapse prevention study
Janssen Submits Supplemental New Drug Application to U.S. FDA for OLYSIO™ (Simeprevir) for Once-Daily Use in Combination with Sofosbuvir for 12 Weeks for the Treatment of Adult Patients with Genotype 1 Chronic Hepatitis C
Filing Includes Data from Treatment-Naïve Patients with Advanced Fibrosis and Null Responders with All Stages of Liver Fibrosis
Janssen Announces Expanded Collaboration with International Partnership for Microbicides for Development and Commercialization of Dapivirine for Prevention of Sexual Transmission of HIV
Latest innovative collaboration from the Janssen Global Public Health group and significant contribution to Johnson & Johnson’s wider efforts to improve public health worldwide
Study Found INVEGA® SUSTENNA® (paliperidone palmitate) Once-Monthly Long-Acting Therapy Delayed Time to and Reduced Risk of Relapse in Individuals with Schizoaffective Disorder as Monotherapy and Adjunctive Therapy
Demonstrated significant efficacy in manic and depressive mood symptoms and psychosis, and improved patient functioning
Landmark Study Shows Once-Monthly Long-Acting Therapy INVEGA® SUSTENNA® (paliperidone palmitate) Significantly Delayed Time to Relapse in Patients with Schizophrenia Compared to Daily Oral Antipsychotic
First prospective, randomized clinical trial to reflect context of “real world” issues in treating schizophrenia, including recent incarceration and substance abuse
SYLVANT™ (siltuximab) Receives FDA Approval to Treat Multicentric Castleman’s Disease (MCD)
First treatment approved for patients with rare blood disorder
Final Data from the Phase 2 COSMOS Study of Janssen’s Once-Daily Simeprevir in Combination with Sofosbuvir Presented at The International Liver Congress™ 2014 of the European Association for the Study of the Liver (EASL)
Additional Studies Presented in Genotype 1 and Genotype 4 Hepatitis C Patient Subgroups Underscore Benefit of Simeprevir-based Treatment Regimens