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GSK ready for lupus drug push

Published on 12/11/15 at 11:09am
GSK is ready to apply for regulatory approval for a new formulation of its lupus drug Benlysta

Having presented positive late-stage results for a new formulation of its inflammatory drug Benlysta, GSK says it will file supplementary drug applications “in the next two to three months.”

The British firm presented the results of the BLISS-SC trial, the third trial in a Phase III program to test a new injectable form of Benlysta (belimumab), for systemic lupus erythematosus, or SLE.

The condition is the most common form of lupus, affecting approximately 70% of an estimated five million people with lupus worldwide. It is a chronic, incurable autoimmune disease producing autoantibodies that can attack almost any system in the body.

The study, presented at the American College of Rheumatology conference in San Francisco, looked at 836 people with active SLE, who were treated with either the new injectable form of Benlysta plus standard of care, or placebo plus standard of care, for one year.

Significantly more patients treated with Benlysta (60.8%) showed reduced disease activity – the study’s primary endpoint – compared to placebo (48.5%). This outcome is a composite measure, combining reduction in disease activity with no significant worsening in any organ system and no worsening in overall patient condition. People treated with Benlysta also had a significantly longer time to a severe flare-up of symptoms, at 170 days, compared to 117 days for those on placebo.

Paul-Peter Tak, who is senior vice-president and head of the immuno-inflammation therapy area unit at GSK, says: “Despite use of current standard of care, such as glucocorticosteroids and immunosuppressants, about 60% of lupus patients continue to experience persistent symptoms and severe disease flares.

“This is GSK’s third successful Phase III study of belimumab in patients with lupus, the results of which reinforce our belief in [it] as a means of reducing underlying disease activity. On the basis of these data, we expect to progress towards global regulatory filings for a belimumab subcutaneous formulation, which if approved, will provide appropriate patients with a new approach to treatment administration.”

Benlysta is the first medicine specifically developed and approved for SLE in 50 years, and the new formation is a 200 milligram dose in an injectable form. Paul-Pater Tak told Pharmafile the company believes it will improve its offerings for people with lupus.

“A sub-cutaneous drug will be a real advantage to patients. SLE primarily affects women at an age where they will be working professionals, or have families, or otherwise don’t want to have to have an intra-venous drug that they have to go to hospital to receive. This will be beneficial and will give much more freedom and independence, and we hope a better quality of life. We plan to file this within two or three months – either late this year or in early 2016.”

He adds: “In terms of our strategic positioning, we have made the decision to be a significant player in inflammatory diseases. We are also testing this drug in other inflammatory conditions, as we believe mechanistically there are reasons why it might work in other diseases. We will also need to do more work to show the value of the secondary endpoint, the importance of a reduction in time to flare-ups, because we believe this is a general principle in immune-mediated diseases.”

Lilian Anekwe

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