Before U.S. markets opened for trading Friday, biopharm company
ChemoCentryx Inc. (CCXI:NASDAQ), which focuses on development and commercialization of therapeutics to treat autoimmune diseases, cancer, inflammatory disorders, and orphan and rare diseases, announced that the U.S. Food and Drug Administration (FDA) has granted approval for its TAVNEOS (avacopan).
ChemoCentryx stated that the FDA approved "TAVNEOS (avacopan), an orally administered selective complement 5a receptor inhibitor, as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (also known as ANCA-associated vasculitis or ANCA vasculitis), specifically granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) (the two main forms of ANCA vasculitis), in combination with standard therapy."
The firm explained that "ANCA-associated vasculitis is a systemic autoimmune disease in which over-activation of the complement system further activates neutrophils, leading to inflammation and eventual destruction of small blood vessels." ANCA-vasculitis causes organ damage and failure especially in the kidneys and is frequently fatal if left unchecked.
ChemoCentryx's President and CEO Thomas J. Schall, Ph.D. commented, "Today is a momentous day in the history of ChemoCentryx; the culmination of decades of effort aimed at offering new hope to patients with this and other debilitating and deadly diseases…We look forward to making TAVNEOS available to clinicians and patients in the next few weeks."
Peter A. Merkel, M.D, MPH, the trial's co-primary academic investigator and Chief of Rheumatology at the Perelman School of Medicine at the University of Pennsylvania, Director of the international Vasculitis Clinical Research Consortium, and consultant to ChemoCentryx, stated "I am excited that our work has helped lead to the first-in-a-decade approval of a medicine for ANCA-associated vasculitis. This is an important step forward in the treatment of this disease…Patients will now have access to a new class of medication that provides beneficial effects for the treatment of ANCA-associated vasculitis."
The Vasculitis Foundation's Executive Director Joyce Kullman remarked, "The vasculitis community is elated that TAVNEOS is now approved, bringing a much-needed new treatment option to patients living with this devastating disease…There is a significant unmet need in the treatment of ANCA-associated vasculitis, with current therapies often leading to serious, even fatal, side effects and a diminished quality of life. We believe new therapies like TAVNEOS may offer a brighter future for these patients."
ChemoCentryx stated that "TAVNEOS is the first FDA approved orally-administered inhibitor of the complement C5a receptor" and advised that TAVNEOS' approval by the FDA for ANCA-associated vasculitis indications was supported by results obtained during its pivotal Phase III ADVOCATE trial.
The Phase 3 ADVOCATE TAVNEOS (avacopan) trial was a 52-week, double-blind study that enrolled 330 patients with ANCA-associated vasculitis in 20 countries. Participants in the study were randomized to receive either rituximab or cyclophosphamide (followed by azathioprine/mycophenolate) and either TAVNEOS (avacopan) or study-supplied oral prednisone.
The company advised that the predetermined primary endpoints identified as "disease remission at 26 weeks and sustained remission at 52 weeks, as assessed by the Birmingham Vasculitis Activity Score, or BVAS," were achieved successfully in the trial. The firm advised that in the study, "TAVNEOS (avacopan) demonstrated superiority to a prednisone-based standard of care with respect to sustained remission at 52 weeks."
The report listed that ChemoCentryx owns the commercial rights to develop and market TAVNEOS (avacopan) in the U.S. The firm has an agreement with Switzerland's Vifor Pharma to commercialize TAVNEOS outside the U.S. The drug is also approved in Japan for use in treating two main forms of ANCA-associated vasculitis.
The company advised that the FDA approved TAVNEOS (avacopan), "a first-in-class, orally-administered small molecule that employs a novel, highly targeted mode of action in complement-driven autoimmune and inflammatory diseases," as an adjunctive treatment of ANCA-associated vasculitis.
ChemoCentryx is a biopharma company based in San Carlos, Calif. that is working to discover, develop and commercialize new medicines for autoimmune and inflammatory diseases and cancer. The firm listed that "it markets TAVNEOSTM (avacopan), the first approved orally-administered inhibitor of the complement 5a receptor as an adjunctive treatment for adult patients with severe active ANCA-associated vasculitis." The company noted that it is also conducting late-stage clinical studies evaluating TAVNEOS in treatment of severe hidradenitis suppurativa, C3 glomerulopathy and lupus nephritis.
ChemoCentryx started off the day Friday with a market cap of around $1.4 billion with approximately 69.9 million shares outstanding and a short interest of about 5.3%. CCXI shares opened 88% higher at $36.98 (+$17.38, +88.67%) over Thursday's $19.60 closing price. The stock traded Friday between $29.07 and $40.80 per share and closed at $38.41.
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.