The US Food and Drug Administration (FDA) has granted approval for a new self-injectable formulation of Benlysta (belimumab) developed by GlaxoSmithKline (GSK). The new product was approved for treating adult patients with active autoantibody-positive systemic lupus erythematosus (SLE).
Vlad Hogenhuis, senior vice president and head of specialty care at GSK, stated: "Lupus can impact the lives of patients in many different ways with varied and often unpredictable symptoms. Since it launched in its IV form, thousands of patients worldwide have received treatment with Benlysta."
Patients will be able to self-administer a 200mg once-weekly dose of the new formulation of Benlysta following training from their health care provider. The drug comes in either a single-dose prefilled syringe or with a single dose auto injector.
"The approval of the new injectable formulation will now provide an additional choice for patients, allowing them to self-administer their medicine at home rather than going to hospitals or clinics for their infusions," Mr Hogenhuis explained.
GSK's announcement of the new Benlysta formulation was welcomed by the Lupus Foundation of America (LSA), which described it as a "major step forward. Susan Manzi, MD, chair of the Department of Medicine of Allegheny Health Network in Pittsburgh and medical director for the LSA, commented: "The new injection formulation of Benlysta will provide a convenient option for our patients who prefer to administer the medication at home instead of taking the time for a one hour infusion at a remote location."
About Benlysta
Approval for the drug was granted following a Phase III pivotal study of more than 800 patients with active SLE. Benlysta is the only medicine specifically developed and approved to treat SLE. It is a BlyS-specific inhibitor that binds to soluble BLyS and inhibits the survival of B cells.
Common side effects of Benlysta include: bacterial infections, such as bronchitis and cystitis; diarrhoea; and nausea. The new formulation of the drug is set to appear in U.S. pharmacies in late August 2017. Belimumab was first approved by the FDA in 2011 and was the first new drug for SLE in more than 50 years.
About Systemic Lupus Erythematosus (SLE)
SLE is an autoimmune disease in which the body's immune system attacks healthy tissue. The cause is unknown, but it can affect the joints, skin, and organs such as the brain and kidneys. Symptoms include: fatigue, chest pain, fever, hair loss, mouth sores and sensitivity to sunlight and a rash. Localized symptoms may also be experienced depending on which part of the body is affected by the condition.
While Benlysta is the only drug specifically formulated to treat SLE, other medications may be used to alleviate symptoms and treat the condition. These include corticosteroids such as Rayos (prednisone), and anti-inflammatory and antirheumatic agents such as Plaquenil (hydroxychloroquine).
