Therapy Areas: Cardiovascular
US FDA Approves Pfizer's Biosimilar, Abrilada for Multiple Inflammatory Conditions
19 November 2019 - - The United States Food and Drug Administration has approved US-based pharmaceutical company Pfizer Inc.'s (NYSE: PFE) Abrilada (adalimumab-afzb), as a biosimilar to Humira (adalimumab), for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis, the company said.
The FDA approval was based on the review of a comprehensive data package, which demonstrated biosimilarity of Abrilada to the reference product.
This includes results from the REFLECTIONS B538-02 clinical comparative study, which evaluated the efficacy, safety and immunogenicity of Abrilada and found no clinically meaningful differences in efficacy, safety or immunogenicity compared to the reference product, each taken in combination with methotrexate, in patients with moderate to severe rheumatoid arthritis.
Biosimilars have been a significant catalyst for change for the healthcare industry over the last decade, with the potential to drive cost savings for healthcare systems.
With more than 10 years of global in-market experience and eight approved biosimilar products in the US, Pfizer is proud to be a leader and at the forefront of this vital healthcare segment.
Pfizer is working to make Abrilada available to US patients as soon as feasible based on the terms of its agreement with AbbVie. Its current plans are to launch in 2023. We will provide further updates as the date approaches.
Abrilada is a tumor necrosis factor blocker and biosimilar to Humira. Adalimumab targets and blocks TNF, which is believed to help reduce inflammation.
Investigational Drug Vericiguat Meets Primary Endpoint in Phase 3 Study of Patients with Worsening Chronic Heart Failure
The Phase 3 VICTORIA study evaluating the efficacy and safety of vericiguat, a soluble guanylate cyclase stimulator being developed to treat patients with worsening chronic heart failure, has met the primary efficacy endpoint, US-based pharmaceutical company Merck's (NYSE: MRK) said.
Since October 2014, German drugmaker Bayer (OTC: BAYZF) and Merck (known as MSD outside of the United States and Canada) are in a worldwide collaboration in the field of sGC modulators. The collaboration brings together two leading companies that have said their intent to fully evaluate this therapeutic class in areas of unmet medical need.
The vericiguat program is being co-developed by Bayer and Merck.
Vericiguat reduced the risk of the composite endpoint of heart failure hospitalization or cardiovascular death in patients with worsening chronic heart failure with reduced ejection fraction (HFrEF) compared to placebo when given in combination with available heart failure therapies. Vericiguat is being jointly developed with Bayer AG.
The results of the VICTORIA study will be presented at an upcoming medical meeting in 2020.
VICTORIA is a randomised, placebo-controlled, parallel-group, multi-center, double-blind, Phase 3 study of vericiguat versus placebo when given in combination with available heart failure therapies in patients with worsening chronic heart failure with reduced ejection fraction (HFrEF) following a decompensation event, defined as heart failure hospitalization or receiving an intravenous diuretic for heart failure without hospitalisation.
The primary endpoint of the study is the composite of time to first occurrence of cardiovascular death or heart failure hospitalisation.
Secondary endpoints include time to occurrence of cardiovascular death, time to first occurrence of heart failure hospitalisation, time to total heart failure hospitalisations (including first and recurrent events), time to the composite of all-cause mortality or heart failure hospitalization, and time to all-cause mortality.
The study enrolled 5,050 patients who were randomised to receive either vericiguat once daily (titrated up to 10 mg) or placebo when given in combination with available heart failure therapies.
The study, which was co-sponsored by Merck and Bayer, was conducted in collaboration with the Canadian VIGOUR Centre and the Duke Clinical Research Institute in more than 600 centers in 42 countries.
Heart failure with reduced ejection fraction (HFrEF), formerly known as systolic heart failure, is characterized by the compromised ability of the heart to eject blood sufficiently during its contraction phase.
In the US, 6.5m people have heart failure, and approximately 40-50% of these patients have HFrEF.
Annually, approximately 30% of patients with symptomatic chronic heart failure will experience worsening of the disease, which is marked by progressive symptoms and/or a recent heart failure event.
Approximately half of patients with worsening chronic HFrEF are rehospitalized within 30 days of the worsening event, and an estimated one in five patients with worsening chronic HFrEF will die within two years.
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