UPLIZNA EFFICACY

In the randomized controlled period UPLIZNA MONOTHERAPY SIGNIFICANTLY REDUCED NMOSD ATTACKS1

Time to onset of adjudicated attack in the AQP4-IgG+ population1

Chart showing UPLIZNA efficacy as an NMOSD treatment through a 77% relative reduction in risk of NMOSD attack at 197 days
  • Attacks that occurred while on treatment with UPLIZNA were less severe than those on placebo (29% major attacks with UPLIZNA vs 45% with placebo)2
  • 78% reduction of NMOSD-related hospitalization rates with UPLIZNA vs placebo in the randomized controlled period1

aCox regression method, with placebo as the reference group1

of patients on UPLIZNA monotherapy were attack free through 28 weeks1

89%

THROUGH THE OPEN-LABEL PERIOD (4+ YEAR COMPLETERS)a

REDUCTIONS IN NMOSD ATTACKS WERE SUSTAINED OVER 4 YEARS3

Probability of AQP4-IgG+ patients remaining attack free after initiation of UPLIZNA (n=75)

Chart showing UPLIZNA efficacy as an NMOSD treatment through a continued reduction in annualized attack rate over a 4 year period

of patients were attack free throughout ≥4 years of UPLIZNA treatment4

83%

aAQP4-IgG+ patients treated with UPLIZNA during N-MOmentum for ≥4 years.

IN THE RANDOMIZED CONTROLLED PERIOD

UPLIZNA PROVIDED DURABLE B-CELL DEPLETION5

Median B-cell counts in AQP4-IgG+ patients

Chart showing UPLIZNA efficacy through B cell depletion at 197 days
  • B-cell depletion was significant vs placebo within 8 days of treatment initiation and remained significant for over 6 months1,5

B-cell reductions remained significant through the open-label period6a

2x Dosing Icon 2x Dosing Icon 2x Dosing Icon

Twice-Yearly Dosing
with UPLIZNA

UPLIZNA is the only approved monotherapy for NMOSD with a twice-yearly dosing schedule after 2 initial start-up doses.1,7

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aFor CD19+ B-cell counts, assays for CD20+ B cells are used because the presence of UPLIZNA interferes with the CD19+ B-cell assay.1

bPatients treated with UPLIZNA during N-MOmentum for ≥4 years.3

AQP4, aquaporin-4; IgG+, immunoglobulin G positive; NMOSD, neuromyelitis optica spectrum disorder; RCP, randomized controlled period.

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

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

IMPORTANT SAFETY INFORMATION

UPLIZNA is contraindicated in patients with:

  • A history of life-threatening infusion reaction to UPLIZNA
  • Active hepatitis B infection
  • Active or untreated latent tuberculosis

WARNINGS AND PRECAUTIONS

Infusion Reactions: UPLIZNA can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or other symptoms. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions. Administer pre-medication with a corticosteroid, an antihistamine, and an anti-pyretic.

Infections: The most common infections reported by UPLIZNA-treated patients in the randomized and open-label periods included urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved.

Increased immunosuppressive effects are possible if combining UPLIZNA with another immunosuppressive therapy.

The risk of Hepatitis B Virus (HBV) reactivation has been observed with other B-cell-depleting antibodies. Perform HBV screening in all patients before initiation of treatment with UPLIZNA. Do not administer to patients with active hepatitis.

Although no confirmed cases of Progressive Multifocal Leukoencephalopathy (PML) were identified in UPLIZNA clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell-depleting antibodies and other therapies that affect immune competence. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation.

Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA.

Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation, until B-cell repletion.

Reduction in Immunoglobulins: There may be a progressive and prolonged hypogammaglobulinemia or decline in the levels of total and individual immunoglobulins such as immunoglobulins G and M (IgG and IgM) with continued UPLIZNA treatment. Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with UPLIZNA until B-cell repletion especially in patients with opportunistic or recurrent infections.

Fetal Risk: May cause fetal harm based on animal data. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for 6 months after stopping UPLIZNA.

Adverse Reactions: The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection and arthralgia.

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

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

IMPORTANT SAFETY INFORMATION

UPLIZNA is contraindicated in patients with:

  • A history of life-threatening infusion reaction to UPLIZNA
  • Active hepatitis B infection
  • Active or untreated latent tuberculosis

WARNINGS AND PRECAUTIONS

Infusion Reactions: UPLIZNA can cause infusion reactions, which can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or other symptoms. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions. Administer pre-medication with a corticosteroid, an antihistamine, and an anti-pyretic.

Infections: The most common infections reported by UPLIZNA-treated patients in the randomized and open-label periods included urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). Delay UPLIZNA administration in patients with an active infection until the infection is resolved.

Increased immunosuppressive effects are possible if combining UPLIZNA with another immunosuppressive therapy.

The risk of Hepatitis B Virus (HBV) reactivation has been observed with other B-cell-depleting antibodies. Perform HBV screening in all patients before initiation of treatment with UPLIZNA. Do not administer to patients with active hepatitis.

Although no confirmed cases of Progressive Multifocal Leukoencephalopathy (PML) were identified in UPLIZNA clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell-depleting antibodies and other therapies that affect immune competence. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation.

Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA.

Vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation, until B-cell repletion.

Reduction in Immunoglobulins: There may be a progressive and prolonged hypogammaglobulinemia or decline in the levels of total and individual immunoglobulins such as immunoglobulins G and M (IgG and IgM) with continued UPLIZNA treatment. Monitor the level of immunoglobulins at the beginning, during, and after discontinuation of treatment with UPLIZNA until B-cell repletion especially in patients with opportunistic or recurrent infections.

Fetal Risk: May cause fetal harm based on animal data. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception during treatment and for 6 months after stopping UPLIZNA.

Adverse Reactions: The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo) were urinary tract infection and arthralgia.

  1. UPLIZNA (inebilizumab-cdon) [prescribing information] Horizon.
  2. Weinshenker BG, Wingerchuk D, Green A, et al. Diagnosis, severity, and recovery of attacks in the N-MOmentum study of inebilizumab in neuromyelitis optica spectrum disorder. Poster 358 presented at: The 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS); September 11-13, 2019 in Stockholm, Sweden.
  3. Rensel M, Zabeti A, Mealy MA, et al. Long-term efficacy and safety of inebilizumab in neuromyelitis optica spectrum disorder: analysis of aquaporin-4-IgG seropositive participants taking inebilizumab for ≥4 years in the N-MOmentum trial. In press.
  4. Cree BAC, Bennett JL, Weinshenker BG, et al. Long-term efficacy outcomes with inebilizumab treatment in neuromyelitis optica spectrum disorder: the N-MOmentum trial. Poster P2329 presented at: The American Association of Neurology (virtual); April 17-22, 2021.
  5. Cree BAC, Bennett JL, Kim HJ, et al. Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmentum): a double-blind, randomised, placebo-controlled phase 2/3 trial. Lancet. 2019;394:1352-1363. doi:10.1016/S0140-6736(19)31817-3.
  6. Data on File. Horizon, June 2020.
  7. Viela Bio announces U.S. FDA Approval of UPLIZNATM (inebilizumab-cdon) for the treatment of neuromyelitis optica spectrum disorder (NMOSD). Press release. Viela Bio. June 11, 2020. Accessed July 7, 2021. https://www.globenewswire.com/news-release/2020/06/11/2047190/0/en/Viela-Bio-Announces-U-S-FDA-Approval-of-UPLIZNA-inebilizumab-cdon-for-the-Treatment-of-Neuromyelitis-Optica-Spectrum-Disorder-NMOSD.html.