Statement on Horizon’s Acquisition of Viela Bio, Inc.
March 15, 2021
Horizon Therapeutics today announced that it has completed the acquisition of Viela Bio, Inc. Horizon is a biotechnology company focused on the discovery, development and commercialization of medicines that address critical needs for people impacted by rare, autoimmune and severe inflammatory diseases. This acquisition aligns with the company’s long-term strategy and evolution into a research and development organization that leads with science and compassion to provide hope to the patients we serve.
We are committed to ensuring a smooth transition for people living with neuromyelitis optica spectrum disorder (NMOSD), health care professionals, infusion centers and others within the NMOSD community. This includes the continuation of the support and services that patients are accustomed to.
At Horizon, patients are at the core of what we do. We actively partner with patient advocacy organizations to raise awareness for many underrepresented diseases and advocate on behalf of patients and their communities. We will apply this approach to our support of the NMOSD community, as well as other disease state communities that we will begin to support as a result of this acquisition.
Information for Patients
People living with NMOSD who are currently taking UPLIZNA should continue to work with their doctor and Viela VIPs representative. For immediate questions, the Viela VIPs team can be reached at 1-833-842-8477 Monday through Friday, 8 a.m. to 8 p.m. ET.
Information for Health Care Professionals
Physicians can continue to communicate with their current Viela representative and use the Patient Referral Form available on VielaVIPs.com to prescribe UPLIZNA. Physicians who have medical questions related to UPLIZNA should call or email Viela Bio Medical Information at 1-855-558-4352 or email@example.com.
Information for Infusion Centers
Infusion centers should continue to infuse patients as medically appropriate and work with their current Viela representative. If you have a question about the transition and would like to speak with someone from Horizon Patient Services, please call 1‐833‐469‐8331 Monday to Friday, 8 a.m. through 8 p.m. ET.
UPLIZNA 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.
For additional information on UPLIZNA, please see Prescribing Information at www.UPLIZNA.com.