Amgen : Latest Acquisition Puts a Spotlight on Rare Autoimmune Disease

TAVNEOS^® (avacopan) is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use.

IMPORTANT SAFETY INFORMATION

Contraindication: Serious hypersensitivity to avacopan or to any of the excipients.

Please see additional Important Safety Information later in this article.

The recent close of Amgen's acquisition of ChemoCentryx, Inc. means that the medicine TAVNEOS has become the newest addition to Amgen's broad and growing portfolio for inflammatory diseases. TAVNEOS (avacopan) is a medicine approved by the FDA as an adjunctive treatment for adults with severe active antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis, a rare disease.

This autoimmune disease is characterized by necrotizing vasculitis that mainly affects small- to medium-sized blood vessels. For people living with severe active ANCA-associated vasculitis, treatment is vital for achieving disease remission. TAVNEOS is used with other treatments to help patients achieve and sustain remission.

An important treatment option for patients with this rare and devastating disease

TAVNEOS is an oral medicine that is thought to work by blocking certain receptors on destructive inflammatory cells - C5a - known to be a driver of severe active ANCA-associated vasculitis and its progression. Treatment plans can include non-specific immunosuppressants, combined with daily glucocorticoids (steroids), which can also lead to significant clinical risks when used for long periods of time. For that reason, significant treatment needs can remain unmet among these patients.

"People with severe active ANCA-associated vasculitis can be classified by their healthcare providers as in remission, and yet still be greatly impacted by this serious disease, with the potential to benefit from additional treatment," says Joyce Kullman, executive director, Vasculitis Foundation. "Last year's FDA approval of TAVNEOS, and now Amgen's involvement in progressing this first-in-class treatment as part of its inflammation portfolio, represent significant progress for the vasculitis community."

Applying decades of experience and global resources to advancing TAVNEOS for patients

Amgen has a long history of developing innovative therapies for inflammatory autoimmune diseases, including moderate to severe rheumatoid and psoriatic arthritis, plaque psoriasis, moderate to severe Crohn's disease and moderate to severe ulcerative colitis. The addition of TAVNEOS to Amgen's inflammation portfolio means the company can apply its expertise, resources and reputation toward continued advancement of the medicine for seriously ill patients.

"TAVNEOS is an important evolution in the standard of care as the only FDA-approved targeted therapy for severe active ANCA-associated vasculitis," says Kave Niksefat, vice president and general manager, Inflammation, at Amgen. "The Amgen inflammation platform has allowed us to develop deep relationships with rheumatologists, who may be treating patients at diagnosis, when relapsing or after relapse. We know the challenges these specialists face and we will be able to help them treat severe active ANCA-associated vasculitis regardless of where their patients are in their journey with this debilitating disease."

Niksefat continues, "We'll be able to amplify the impact of this medicine for patients by working deeply with providers, payers and patient advocacy groups. Our North Star here will be to ensure that the vast majority of patients can access TAVNEOS within one week of receiving a prescription from their physician, with minimal hurdles."

Advocacy also key to serving people living with this condition

When it comes to rare and complex diseases like ANCA-associated vasculitis, it's not enough to simply have a medicine like TAVNEOS on the market. Amgen has also committed to assisting advocacy groups like the Vasculitis Foundation and others in the ANCA-associated vasculitis community by working with leading experts and creating resources to help to reach and educate both patients and the specialists who care for them.

"The Vasculitis Foundation looks forward to partnering with Amgen on expanding awareness of this devastating rare disease," Kullman adds. "Our goal is to keep improving the quality of care and access to treatment that people with severe active ANCA-associated vasculitis need and deserve."

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: Serious hypersensitivity to avacopan or to any of the excipients

WARNING AND PRECAUTIONS

Hepatotoxicity: Serious cases of hepatic injury have been observed in patients taking TAVNEOS, including life-threatening events. Obtain liver test panel before initiating TAVNEOS, every 4 weeks after start of therapy for six months and as clinically indicated thereafter. Monitor patients closely for hepatic adverse reactions, and consider pausing or discontinuing treatment as clinically indicated (refer to section 5.1 of the Prescribing Information). TAVNEOS is not recommended for patients with active, untreated and/or uncontrolled chronic liver disease (e.g., chronic active hepatitis B, untreated hepatitis C, uncontrolled autoimmune hepatitis) and cirrhosis. Consider the risk and benefit before administering this drug to a patient with liver disease.

Serious Hypersensitivity Reactions: Cases of angioedema occurred in a clinical trial, including one serious event requiring hospitalization. Discontinue immediately if angioedema occurs and manage accordingly. TAVNEOS must not be re-administered unless another cause has been established.

Hepatitis B Virus (HBV) Reactivation: Hepatitis B reactivation, including life threatening hepatitis B, was observed in the clinical program. Screen patients for HBV. For patients with evidence of prior infection, consult with physicians with expertise in HBV and monitor during TAVNEOS therapy and for six months following. If patients develop HBV reactivation, immediately discontinue TAVNEOS and concomitant therapies associated with HBV reactivation, and consult with experts before resuming.

Serious Infections: Serious infections, including fatal infections, have been reported in patients receiving TAVNEOS. The most common serious infections reported in TAVNEOS group were pneumonia and urinary tract infections. Avoid use of TAVNEOS in patients with active, serious infection, including localized infections. Consider the risks and benefits before initiating TAVNEOS in patients with chronic infection, at increased risk of infection or who have been to places where certain infections are common.

ADVERSE REACTIONS: The most common adverse reactions (≥5% of patients and higher in the TAVNEOS group vs. prednisone group) were: nausea, headache, hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal pain, dizziness, blood creatinine increased, and paresthesia.

DRUG INTERACTIONS: Avoid coadministration of TAVNEOS with strong and moderate CYP3A4 enzyme inducers. Reduce TAVNEOS dose when co-administered with strong CYP3A4 enzyme inhibitors to 30 mg once daily. Monitor for adverse reactions and consider dose reduction of certain sensitive CYP3A4 substrates.

Please see Full Prescribing Information and Medication Guide.

Learn More:

About Granulomatosis with Polyangiitis (GPA):
https://www.vasculitisfoundation.org/education/granulomatosis-with-polyangiitis-gpa-wegeners/

About Microscopic Polyangiitis (MPA):
https://www.vasculitisfoundation.org/education/forms/microscopic-polyangiitis/

TAVNEOS Connect:
https://www.tavneos.com/support