FDA Approves Amgen's AVSOLA (infliximab-axxq), For The Same Indications As Remicade (infliximab)
[caption id="attachment_9277" align="aligncenter" width="747"] Press Release[/caption]
Amgen's Fourth FDA Approval From Biosimilars Portfolio
THOUSAND OAKS, Calif.,?Dec. 6, 2019?/PRNewswire/ --?Amgen?(NASDAQ:AMGN) today announced that the?U.S. Food and Drug Administration?(FDA) has approved AVSOLA? (infliximab-axxq) for all approved indications of the reference product, Remicade??(infliximab): for the treatment of moderate-to-severe rheumatoid arthritis (RA), moderate-to-severe Crohn's Disease (CD) in the adult and pediatric population, moderate-to-severe ulcerative colitis (UC) in the adult and pediatric population, chronic severe plaque psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS).
"The approval of AVSOLA?represents an important milestone across our biosimilar and inflammation portfolios," said?Murdo Gordon, executive vice president of Global Commercial Operations at?Amgen. "Following July's exciting launches of our two biosimilars in oncology, AVSOLA?highlights?Amgen's?long-term commitment to providing more affordable biological treatment options to patients across critical disease states, including chronic inflammatory conditions."
AVSOLA,?an anti-tumor necrosis factor alpha (anti-TNF) monoclonal antibody, was proven to be highly similar to Remicade?with no clinically meaningful differences based on a totality of evidence which included comparative analytical, nonclinical and clinical data. The data package was composed of, in part, results from a pharmacokinetic (PK) similarity study conducted in healthy subjects, and a comparative clinical study conducted in patients with moderate to severe RA.
The randomized, double-blind comparative clinical study evaluated the efficacy and safety of AVSOLA?compared to Remicade?in patients with moderate-to-severe RA. There were 558 patients enrolled and randomized (1:1) to receive either AVSOLA or Remicade?at a dose of 3 mg/kg administered as an infusion on day 1, at weeks 2 and 6, and every 8 weeks thereafter.?The primary endpoint was the response difference (RD) of 20% improvement in?American College of Rheumatologycore set measurements (ACR20) at week 22. Key secondary endpoints included DAS28-CRP change from baseline, RD of ACR20, ACR50 and ACR70 at weeks 2, 6, 14, 22, 30, 34, 38, 46 and 50. The study also?incorporated the evaluation of a single transition in 119 subjects from Remicade?to AVSOLA at week 22, which demonstrated similar safety and immunogenicity in patients who were previously on Remicade.
Amgen?has a total of 10 biosimilars in its portfolio, four of which have been approved in the U.S., and 3 that are approved in the?European Union?(EU).
About?AVSOLA??(infliximab-axxq)?in the U.S.
AVSOLA is a biosimilar to Remicade, an anti-tumor necrosis factor alpha (anti-TNF) monoclonal antibody. The active ingredient of AVSOLA?is an anti-TNF monoclonal antibody that has the same amino acid sequence as Remicade. AVSOLA also has the same pharmaceutical dosage form and strength as Remicade.
AVSOLA is currently not available commercially.? This is not an offer for sale.?The following information is derived from the approved label in the U.S.
In the U.S., AVSOLA is approved for:
Rheumatoid Arthritis
AVSOLA, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis.
Crohn's Disease
AVSOLA is indicated for
- reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy.
- reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn's disease.
- Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease.?Patients should be tested for latent TB before AVSOLA use and during therapy. Treatment for latent infection should be initiated prior to AVSOLA use.
- Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, pneumocystosis, and cryptococcosis. Patients may present with disseminated, rather than localized, disease. Empiric antifungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
- Bacterial, viral and other infections due to opportunistic pathogens, including Legionella, Listeria and Salmonella.
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SOURCE?Amgen