FDA issues CRL to Janssen Biotech for golimumab sBLA

September 12, 2011

FDA has issued a complete response letter for a golimumab (Simponi, Janssen Biotech) supplemental Biologics License Application seeking an expanded label in the treatment of active psoriatic arthritis.

FDA issued a complete response letter (CRL) for a golimumab (Simponi, Janssen Biotech) supplemental Biologics License Application (sBLA) seeking an expanded label in the treatment of active psoriatic arthritis.

The application, filed in November 2010, included data from a phase 3 trial evaluating the effect of golimumab in inhibiting the progression of structural damage and maintaining improvement in signs and symptoms and physical function in the treatment of patients with active psoriatic arthritis.

Janssen said that it intends to request an end-of-review meeting with FDA to thoroughly understand the details of the CRL and discuss what future steps may be necessary to achieve the desired approval.

“We believe the data from the Simponi phase 3 study support the proposed label expansion in the treatment of active psoriatic arthritis,” said Jerome A. Boscia, MD, vice president, head of immunology development, Centocor Research & Development division of Johnson & Johnson Pharmaceutical Research & Development, in a company press release. “We look forward to meeting with the agency to identify a path forward.”

Simponi is a human monoclonal antibody that targets and neutralizes excess tumor necrosis factor-alpha (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 available through either the Simponi SmartJect autoinjector or a prefilled syringe.

In 2009, Simponi received approvals in the United States, Europe, and Canada for the treatment of moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate, as a once-monthly subcutaneously administered anti-tumor necrosis factor (TNF)-alpha treatment of active psoriatic arthritis and active ankylosing spondylitis.

In May 2011, the European Commission approved a new indication for Simponi in the treatment of active and progressive psoriatic arthritis to reduce the rate of progression of peripheral joint damage as measured by X-ray in psoriatic arthritis patients with polyarticular symmetrical subtypes of the disease. This information was added to the existing therapeutic indication for the use of Simponi, alone or in combination with methotrexate, for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous disease-modifying antirheumatic drug therapy has been inadequate.

According to product safety information, golimumab should not be started if the patient has any kind of infection. The doctor or healthcare professional must be notified if the patient is prone to or has a history of infections, or has diabetes, HIV, or a weak immune system. The patient also should inform the healthcare provider if he or she is currently being treated for an infection or if he or she develops any signs of infection, such as fever, perspiration, or chills; muscle aches; cough; shortness of breath; blood in phlegm; weight loss; warm, red, or painful skin or sores on the body; diarrhea or stomach pain; burning when urinating or urinating more than normal; or feeling very tired.

Unusual cancers have been reported in children and teenage patients taking TNF-blocking medications. For children and adults taking TNF blockers, including golimumab, the risk of lymphoma or other cancers may increase.