FDA Update

FDA Update

FDA approves Mvasi (bevacizumab-awwb), a Biosimilar to Avastin

The U.S. Food and Drug Administration approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer. Mvasi is approved for the treatment of adult patients with certain colorectal, lung, brain, kidney and cervical cancers.

FDA Approves Vosevi (sofosbuvir/velpatasvir/voxilaprevir) for re-treatment of adults with Chronic Hepatitis C Virus

The USFDA has approved Vosevi (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg) tablets, a single-tablet regimen for the re-treatment of Chronic Hepatitis C Virus (HCV) infection in adults with genotype 1, 2, 3, 4, 5 or 6 previously treated with an NS5A inhibitor-containing regimen, or with genotype 1a or 3 previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor. The approval is based on data from the Phase 3 POLARIS-1 and POLARIS-4 studies, which evaluated 12 weeks of Vosevi in direct-acting antiviral-experienced chronic HCV-infected patients without cirrhosis or with compensated cirrhosis. Vosevi has a boxed warning in its product label regarding the risk of hepatitis B virus (HBV) reactivation in HCV/HBV coinfected patients. Vosevi is the latest single-tablet regimen in Gilead’s portfolio of sofosbuvir-based DAA treatments that offer people living with HCV a short course of therapy to cure their HCV, with the convenience associated with once-daily single-tablet regimens. Since 2013, Gilead has brought to market four HCV treatments, including 3 single-table regimens. To date, more than an estimated 1.4 million patients worldwide have been treated with sofosbuvir-based regimens.

 FDA approves Vabomere (meropenem and vaborbactam) for complicated Urinary Tract Infections

The USFDA recently approved Vabomere for adults with complicated urinary tract infections (cUTI), including a type of kidney infection, pyelonephritis, caused by specific bacteria. Vabomere is a drug containing meropenem, an antibacterial, and vaborbactam, which inhibits certain types of resistance mechanisms used by bacteria. The safety and efficacy of Vabomere were evaluated in a clinical trial with 545 adults with cUTI, including those with pyelonephritis. At the end of intravenous treatment with Vabomere, approximately 98 percent of patients treated with Vabomere compared with approximately 94 percent of patients treated with piperacillin/tazobactam, another antibacterial drug, had cure/improvement in symptoms and a negative urine culture test. Approximately seven days after completing treatment, approximately 77 percent of patients treated with Vabomere compared with approximately 73 percent of patients treated with piperacillin/tazobactam had resolved symptoms and a negative urine culture.

 The most common adverse reactions in patients taking Vabomere were headache, infusion site reactions and diarrhea. Vabomere is associated with serious risks including allergic reactions and seizures. Vabomere should not be used in patients with a history of anaphylaxis, a type of severe allergic reaction to products in the class of drugs called beta-lactams. To reduce the development of drug-resistant bacteria and maintain the effectiveness of antibacterial drugs, Vabomere should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

 FDA approves Kymriah (tisagenlecleucel) CAR-T Gene Therapy for acute Lymphoblastic Leukemia

The U.S. Food and Drug Administration issued a historic action making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases. The FDA approved Kymriah (tisagenlecleucel) for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL). Kymriah is a genetically-modified autologous T-cell immunotherapy. Each dose of Kymriah is a customized treatment created using an individual patient’s own T-cells, a type of white blood cell known as a lymphocyte. The patient’s T-cells are collected and sent to a manufacturing center where they are genetically modified to include a new gene that contains a specific protein (a chimeric antigen receptor or CAR) that directs the T-cells to target and kill leukemia cells that have a specific antigen (CD19) on the surface. Once the cells are modified, they are infused back into the patient to kill the cancer cells.

 Sanofi receives tentative FDA approval of Admelog (insulin lispro injection) 100 units/mL

Sanofi announced that the U.S. Food and Drug Administration (FDA) granted tentative approval for Admelog® (insulin lispro injection) 100 Units/mL, a rapid-acting human insulin analog. Admelog is indicated to improve glycemic control in adults and children with diabetes mellitus. The tentative approval is based on physicochemical, non-clinical and clinical similarity to another insulin lispro 100 Units/mL as currently approved in the U.S., including data from a clinical development program involving more than 1,000 adults living with type 1 or type 2 diabetes. Admelog is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin lispro or one of its other ingredients.

FDA clears Novo Nordisk's diabetes drug to treat heart disease

Novo Nordisk announced that the US Food and Drug Administration (FDA) approved its diabetes drug as a treatment to reduce the risk of three major cardiovascular diseases. This is the first time the FDA has cleared a diabetes drug to treat heart–related diseases in patients with type 2 diabetes, the company said in a statement.  Type 2 diabetes, closely linked to obesity, accounts for more than 90% of all diabetes cases, the company said. Victoza’s expanded label follows a successful trial that showed the drug significantly reduced the risk of cardiovascular death, non–fatal heart attack or non–fatal stroke by 13% when compared to a placebo.

  Dhaka -

Saturday 18 Nov 2017

2016 © THE PHARMA WORLD. All Rights Reserved.