FDA approval provides a new treatment option for complicated urinary tract infections
On Nov. 14, 2019, the U.S. Food and Drug Administration (FDA) Fetroja® (cefiderocol) for the treatment of patients 18 years of age or older with complicated urinary tract infections (cUTI), including kidney infections, who have limited treatment alternatives. UTIs are common infections that occur when bacteria enter the urinary tract and are commonly characterized by frequent and painful urination. Increasingly, however, common infections are becoming resistant to major antibiotic treatments which has become a key challenge facing the FDA. John Farley, the acting director of the Office of Infectious Diseases at the agency, says the approval of Fetroja® is a “step forward in the FDA’s efforts to ensure safe and effective antimicrobial drugs are available to patients.” According to the Centers for Disease Control and Prevention (CDC), drug resistant infections are estimated to affect at least 2.8 million people and result in over 35,000 deaths annually.
Dollar Tree stores receive warning letter from FDA for drug safety concerns
On Nov. 14, 2019, the U.S. FDA announced that they have issued a warning letter to Dollar Tree stores for receiving over-the-counter (OTC) products from foreign manufacturers that have committed serious violations of federal law surrounding their manufacturing practices. The warning letter details multiple violations committed by manufacturers that are contracted to produce Dollar Tree’s line of OTC medication, known as Assured Brand, and other Dollar Tree drug products. Manufacturing violations by the identified manufacturers include not testing raw materials and finished products for quality. The FDA’s warning letter to Dollar Tree details the corrective actions the agency requested, including a request for Dollar Tree stores to implement a system to ensure that they do not import adulterated drugs.
From the Industry
FDA advisory panel votes in favor of Vascepa® as add-on therapy in heart disease
On Nov. 14, 2019, Amarin pharmaceuticals announced that an FDA advisory panel voted unanimously (16-0) to expand the label of its prescription drug, Vascepa® (icosapent ethyl). Vascepa® is currently indicated to reduce triglycerides (TG) in combination with diet and exercise in patients with high triglycerides (>500 mg/dL). The committee recommended to expand the label beyond TG reduction to include reducing the risk of heart-related events in patients with heart disease when used in combination with statins. The recommendation was based on data from the REDUCE-IT trial, which showed that the addition of Vascepa® to statin therapy reduced the risk of heart-related events by 25% compared to statin therapy plus placebo. Although the panel unanimously recommended to expand the label, the final decision lies in the hands of the FDA, which is expected to make a final decision by Dec. 28, 2019.
Recent FDA Approvals
Novel Drug Approval: Reblozyl® (luspatercept-aamt)
Subcutaneous injection for the treatment of low blood oxygen in adult patients with beta thalassemia, a blood disease that requires regular red blood cell (RBC) transfusions [11/8/2019 – Fast Track; Orphan Drug – CELGENE CORP]
Novel Drug Approval: BrukinsaTM (zanubrutinib)
Oral capsule for the alternative treatment of adult patients with mantle cell lymphoma (MCL), a rare cancer of the white blood cells and bone marrow [11/14/2019 – Orphan Drug; Priority Review – BEIGENE USA INC]
Novel Drug Approval: Fetroja® (cefiderocol)
Intravenous injection for the treatment of patients 18 years of age or older with complicated urinary tract infections (cUTI), including kidney infections, who have limited alternative options [11/14/2019 – Priority Review; Qualified Infectious Disease Product – SHIONOGI & CO LTD]
New Generics Entering the Marketplace
Indication: Chronic Iron Overload
Dosage Form/Strength: 90MG, 360MG Tablet
Average Wholesale Price (AWP): Generic = $15,962 | Brand = $17,026