FDA approved Enspryng (satralizumab-mwge) for Anti-AQP4 Positive Neuromyelitis Optica Spectrum DisorderFDA approved new injectable drug for rare autoimmune nerve disorder

Enspryng is an interleukin-6 (IL-6) receptor antagonist. By binding to the IL-6 receptor, it blocks IL-6 mediated signaling, which is thought to play a role in the pathogenesis of NMOSD.

Enspryng is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

For subcutaneous use only. The recommended loading dosage is 120 mg by subcutaneous injection at Weeks 0, 2, and 4, followed by a maintenance dosage of 120 mg every 4 weeks. Prior to every use, determine if there is an active infection; if active infection is present, delay use until the infection is resolved. Missed doses should be managed according to the label (see Table 1). ENSPRYNG is intended for patient self-administration under the guidance of a health care professional after proper training. Prior to use, remove from refrigerator and allow to sit at room temperature for 30 minutes. Inspect visually for particulate matter and discoloration; solution should be clear and colorless to slightly yellow. Do not use if cloudy, discolored, or contains particles.

Trial data not available in label.

ENSPRYNG is contraindicated in patients with active hepatitis B virus (HBV) confirmed by positive results for surface antigen [HBsAg] and anti-HBV tests. Prior to initiating ENSPRYNG, perform HBV screening. For patients who are negative for HBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult liver disease experts before starting and during treatment. Evaluate for active tuberculosis and test for latent infection; for patients with active tuberculosis or positive tuberculosis screening without a history of appropriate treatment, consult infectious disease experts before initiating treatment. Assess liver transaminases and serum bilirubin prior to initiation; caution should be exercised when considering initiation in patients with AST or ALT greater than 1.5 times the upper limit of normal. Because vaccination with live-attenuated or live vaccines is not recommended during treatment, administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation for live or live-attenuated vaccines and, whenever possible, at least 2 weeks prior to initiation for non-live vaccines. Patients should seek immediate medical attention if symptoms of a serious allergic reaction occur and should not administer further doses until evaluated by a health care professional.

ENSPRYNG provides a subcutaneous treatment option for adult patients with anti-AQP4 antibody-positive NMOSD. Its place in therapy relative to other agents is not specified in the label.