EU Regulators Approve Self-injectable Belimumab for Lupus

EU Regulators Approve Self-injectable Belimumab for Lupus

The European Medicines Agency (EMA) has recommended approval of a self-injectable form of belimumab (Benlysta, GlaxoSmithKline) as an add-on therapy for adults with the most common form of lupus, sparing them the need to go to hospitals or clinics to have the drug infused intravenously, the agency announced today.

Belimumab is indicated in the European Union (EU) for patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who have a highly active form of the disease despite standard therapy. The drug will become available as a 200 mg solution for weekly subcutaneous injections in pre-filled syringes and pens.

A human monoclonal antibody, belimumab shortens the lifespan of B lymphocytes, which are responsible for the inflammation and organ damage that occur in SLE. The drug was licensed in the EU as an intravenous treatment for patients with SLE in 2011, the same year that the US Food and Drug Administration (FDA) approved it for that indication. The FDA greenlighted the self-injectable version in July.

Both the FDA and EMA okayed self-injectable belimumab based on a randomized, double-blind, placebo-controlled study called BLISS-SC. The 52-week study, published in Arthritis & Rheumatology in May, found that weekly subcutaneous doses of belimumab 200 mg plus standard SLE therapy reduced disease activity as early as week 16. Patient reported lower levels of fatigue as well. The drug’s safety profile resembled that for the form of belimumab infused intravenously.

The most common adverse events associated with intravenously administered belimumab include bacterial infections, diarrhea, and nausea, according to the EMA.

GlaxoSmithKline stated in a news release that self-injectable belimumab is not recommended for patients with:

• Severe active central nervous system lupus

• Severe active lupus nephritis

• HIV

• Hepatitis B or C, or a history of having either infection

• Hypogammaglobulinaemia or IgA deficiency

• A history of major organ transplant, hematopoietic stem/cell/marrow transplant, or renal transplant

The EMA’s Committee for Medicinal Products for Human Use made the recommendation to approve self-injectable belimumab. The final decision on market authorization now lies with the European Commission, the EU’s executive branch.

 

 

More information about the EMA decision is available on the agency’s website.

Follow Robert Lowes on Twitter @LowesRobert

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