J&J Submits NDA for New Dosing for Paliperidone; Seeks New Indication in EU for Simponi

Janssen Research & Development, LLC, part of Johnson & Johnson, has announced the submission of a new drug application (NDA) for three-month atypical antipsychotic paliperidone palmitate to the US Food and Drug Administration (FDA). The NDA seeks approval for the medication as a treatment for schizophrenia in adults. If approved, it will be the first and only long-acting atypical antipsychotic that has a four times a year dosing schedule, according to the company.

Invega Sustenna (paliperidone palmitate) was approved by the FDA in July 2009 as a once-monthly atypical long-acting injection to treat schizophrenia and is now approved in more than 80 countries. Efficacy was established in four short-term studies and one longer-term study in adults. Janssen Pharmaceuticals, Inc. markets Invega Sustenna in the United States. Invega Sustenna and the three-month paliperidone palmitate use Alkermes' proprietary NanoCrystal technology, which enables solubility of poorly water-soluble compounds.

In other news, Janssen Biologics B.V. has filed a Type II Variation with the European Medicines Agency seeking approval of Simponi (golimumab) for the treatment of severe active non-radiographic axial spondyloarthritis (nr-AxSpA). Nr-AxSpA is a form of spondyloarthritis—chronic inflammatory diseases affecting the spine—in which the predominant symptom is back pain and stiffness. While patients with nr-AxSpA may not initially present with evidence of structural damage to the joints, many will progress to having some degree of spinal fusion (e.g., ankylosing spondylitis), particularly young males.

Simponi is a human monoclonal antibody that targets and neutralizes excess tumor necrosis factor (TNF)-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue. It is approved in 85 countries for rheumatologic indications, including the EU, where it received European Commission approval in October 2009 for the treatment of moderate-to-severe, active rheumatoid arthritis in combination with methotrexate, for the treatment of active and progressive psoriatic arthritis alone or in combination with methotrexate and for the treatment of severe, active ankylosing spondylitis. In September 2013, Simponi received European Commission approval for the treatment of moderately-to-severely active ulcerative colitis. It is available either through the SmartJect autoinjector/prefilled pen or a prefilled syringe as a subcutaneously administered injection.

In Europe, Russia and Turkey, Janssen Biotech. licenses distribution rights to Simponi to Schering-Plough (Ireland) Company, a subsidiary of Merck & Co., Inc. In Japan, Indonesia, and Taiwan, Janssen Biotech licenses distribution rights to Simponi to Mitsubishi Tanabe Pharma Corporation and has retained co-marketing rights in those countries.

Source: Johnson & Johnson (paliperidone) and Johnson & Johnson (Simponi)

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