FDA: New Options for Meningitis, Hemophilia A, Stroke

Savaysa: Systemic Embolic Events in Patients with Non-Valvular Atrial Fibrillation

The FDA has approved Savaysa (edoxaban),¹ a once daily, 60 mg anticoagulant, for the prevention of stroke and systemic embolic events in individuals with non-valvular atrial fibrillation.

Savaysa works by inhibiting factor Xa, which is important in the clotting of blood.

Savaysa was shown to meet the endpoint of non-inferiority to warfarin and demonstrated significantly less major bleeding than warfarin in a review of the ENGAGE AF-TIMI 48 study.

The drug is still under consideration for approval for the treatment of symptomatic venous thromboembolism.
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Trumenba: Serogroup B Meningococcal Disease

The FDA has approved Trumenba,² a vaccine to prevent the strain of bacterial meningitis caused by Neisseria meningitidis serogroup B in individuals age 10-25.

This form of bacterial meningitis, caused by infection of the bloodstream and lining surrounding the brain and spinal cord, was responsible for the outbreaks of meningitis on college campuses in Santa Barbara, CA, and Princeton, NJ, late last year.

Until Trumenba, only vaccines for meningitis A, C, Y, and W have been available in the United States.

The vaccine’s safety was evaluated in a meta-analysis of about 4500 individuals across the US, Europe, and Australia. 

The most common side effects were headache, diarrhea, muscle pain, joint pain, fatigue, and chills.

Obizur: Hemophilia A

The FDA has approved Obizur (antihemophilic factor [recombinant], porcine sequence)³ for the treatment of hemophilia A (acquired factor VIII [FVIII] deficiency)—a rare, life threatening bleeding disorder.

Hemophilia A is caused by attacks against FVIII, a protein important to blood clotting, by the body’s own antibodies. Unlike the more common form of hemophilia, which is a genetic condition, hemophilia A is an acquired condition with no discernable underlying cause in nearly 50% of reported cases.

Obizur uses a recombinant analogue of porcine FVIII, similar enough to human FVIII to assist in blood clotting, but different enough to not be targeted by antibodies present in patients with hemophilia A.

The drug’s safety was evaluated in a clinical trial of 29 adults with hemophilia A using Obizur to treat a severe bleeding episode. No side effects were noted.

—Michael Potts

References:

1. Daiichi-Sankyo. US FDA cardiovascular and renal drugs advisory committee makes recommendation on daiichi sankyo’s once-daily Savaysa (edoxaban) for the reduction in risk of stroke and systemic embolic events in patients with non-valvular atrial fibrillation [press release]. October 31, 2014. www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/006206.html. Accessed October 31, 2014.

2. FDA. First vaccine approved by FDA to prevent serogroup B meningococcal disease [press release]. October 29, 2014. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm420998.htm. Accessed October 31, 2014.

3. FDA. FDA approves new treatment for rare form of hemophilia [press release]. October 24, 2014. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm420263.htm. Accessed October 31, 2014.