Formulary Watch |

First combination therapy for advanced melanoma approved

FDA approved trametinib (Mekinist, GlaxoSmithKline) in combination with dabrafenib (Tafinlar, GlaxoSmithKline) to treat patients with advanced melanoma that is unresectable or metastatic.

Drugs in Perspective: Takeda's and Lundbeck’s Brintellix

Major depressive disorder (MDD) is a medical illness that is characterized by depressed mood, hopelessness, and loss of interest.1 According to the National Institute of Mental Health (NIMH), approximately 6.7% of US adult population experienced MDD, with 30.4% of these cases (2.0% of U.S. adult population) classified as severe.

Farxiga rebounds, approved to treat type 2 diabetes

FDA has approved dapagliflozin tablets (Farxiga, Bristol-Myers Squibb and AstraZeneca) to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. This marks a rebound for the drug, which FDA rejected last year, citing concerns raised by studies linking the drug to bladder cancer and liver toxicity.

Analysis: Increased OS with higher cumulative dose of bortezomib in patients with previously untreated multiple myeloma

A higher cumulative dose of bortezomib (Velcade, Millennium: The Takeda Oncology Company) suggested improved overall survival (OS) in previously untreated multiple myeloma patients, according to results from a retrospective subgroup analysis of the phase 3 VISTA study.

Updated data with oral proteasome inhibitor reported in newly diagnosed multiple myeloma patients

An investigational all-oral proteasome inhibitor-MLN9708 (Millennium: The Takeda Oncology Company)-plus lenalidomide and dexamethasone generated high response rates and increased depth of response with extended treatment duration in newly diagnosed multiple myeloma patients, according to data presented at the American Society of Hematology (ASH) 2013 annual meeting in New Orleans.

Evolocumab meets primary end point of LDL cholesterol reduction in phase 3 study

Evolocumab (Amgen) may offer a new treatment option for patients with dyslipidemia, according to new data from a phase 3 study.

Baxter voluntarily recalls select lots of premix parenteral nutrition

Baxter International has initiated a voluntary recall in the United States of 2 lots of premixed sterile intravenous (IV) parenteral nutrition products: CLINIMIX (Amino Acid in Dextrose) Injection and CLINIMIX E (Amino Acid with Electrolytes in Dextrose with Calcium) Injections to the user level because of complaints of particulate matter found in the products.

Early antibiotics, combined antibiotic therapy cut CAP deaths in ICU

In the last decade, ICU mortality due to severe pneumococcal pneumonia has significantly decreased. Improved survival is associated with earlier antibiotic prescribing and an increased use of combined antibiotic therapy, according to a study reported online in Chest.

FDA drug approvals: January 2014

FDA approvals, complete response, fast-track designations, priority review, first-time generic approval

Baxter voluntarily recalls select lots of premix parenteral nutrition

Baxter International has initiated a voluntary recall in the United States of 2 lots of premixed sterile intravenous (IV) parenteral nutrition products: CLINIMIX (Amino Acid in Dextrose) Injection and CLINIMIX E (Amino Acid with Electrolytes in Dextrose with Calcium) Injections to the user level because of complaints of particulate matter found in the products.

FDA approvals total 27 in 2013

FDA approved 27 new drugs last year, down from 39 new medications in 2012, which was a 15-year high, the Associated Press reported.

For the new healthcare landscape: A new Formulary brand

In just 1 year, with the rollout of the Affordable Care Act, the healthcare landscape has undergone its most far-reaching change in decades.

Drug safety and efficacy data lacking for neonates

Despite some key pieces of federal legislation passed in recent years, most drugs-about 93%-are still not studied in neonates. Of those drugs that researchers have studied in this vulnerable population and that bear labels reflecting the changes in pediatric prescribing information, only about half (54%) are used in the neonatal intensive care unit (NICU).

Stricter bioequivalence rules may be needed for generic antiepilepsy treatments

Ongoing studies may lead FDA to stiffen its bioequivalence rules for generic antiepileptic drugs (AEDs) and others with so-called narrow therapeutic indices, according to research presented at American Epilepsy Society (AES) annual meeting recently in Washington, D.C., according to MedPage Today.

NECC settlement establishes $100 million fund for victims

Last week, the New England Compounding Center's owners and insurers agreed to establish a $100 million compensation fund for its creditors, including the victims who were injured after receiving injections of contaminated steroids produced by the now bankrupt NECC. Victims have until Wednesday, January 15 to submit their claims in the case.

FDA rejects MS drug

FDA has rejected alemtuzumab (Lemtrada, Genzyme, a Sanofi company) for the treatment of relapsing forms of multiple sclerosis.

New enrollees in healthcare exchanges to pay more of drug costs

The newly enrolled individuals to the healthcare exchanges will be faced with higher out-of-pocket costs for their medications than those who receive insurance through their employers, according to an analysis by Avalere Health of more than 600 health plans in the exchanges.

FDA approves first once-daily dual bronchodilator for COPD

FDA approved umeclidinium and vilanterol inhalation powder (Anoro Ellipta, GlaxoSmithKline and Theravance) for the once-daily, long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

FDA approves Kcentra for warfarin reversal in emergency surgery patients

FDA expanded the indication for Prothrombin Complex Concentrate [Human] (Kcentra, CSL Behring) for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, eg, warfarin) therapy in adult patients needing an urgent surgery or other invasive procedure.

Amneal launches delayed-release proton pump inhibitor for GERD

Amneal Pharmaceuticals will start shipping its branded Esomeprazole Strontium 49.3 mg delayed-release capsules on December 18 to three major U.S. wholesalers. Its capsules contain the same active ingredient, esomeprazole, in a different salt form as found in Nexium (esomeprazole magnesium).

Progress in treating cancer continues to surge

US life expectancy for people with cancer hit another all-time high, rising over 50 million life-years (LYS) after diagnosis, according to statistics collected through the Value of Medical Innovation initiative, led by the Center for Medicine in the Public Interest (CMPI).

FDA proposed rule requires antibacterial soap manufacturers to prove safety, effectiveness

Manufacturers of antibacterial hand soap and body wash will be required to show that their products are more effective than plain soap and water in preventing illness and the spread of infection, under a FDA-proposed rule.

Earlier, more aggressive RA treatment produce better outcomes than 20 years ago

Individuals diagnosed with rheumatoid arthritis (RA) more recently experienced decreased disability and psychological problems than those treated 20 years ago. While treatment strategies have helped, researchers attribute the positive effects to greater physical activity and encouragement of a worthwhile life by healthcare professionals.

Penicillin as effective as “big gun” antibiotics for treating less-severe childhood pneumonia

Children hospitalized for pneumonia have similar outcomes, including length of stay and costs, regardless of whether they are treated with “big gun” antibiotics such as ceftriaxone or cefotaxime or more narrowly focused antibiotics such as ampicillin or penicillin, according to a Vanderbilt study published in Pediatrics.

CVS Caremark and Cardinal Health team up to supply generic drugs

CVS Caremark and Cardinal Health are about to become the single biggest supplier of generic drugs in the United States.

Diabetes: A risk factor for liver cancer across ethnic groups

Diabetes was associated with an increased risk for developing hepatocellular carcinoma, a type of liver cancer, and this association was highest for Latinos, followed by Hawaiians, African-Americans, and Japanese-Americans, according to results presented here at the Sixth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved, held Dec. 6-9, in Atlanta.

FDA approves the first generic versions of depression drug Cymbalta

FDA announced that it had given approval to several pharmaceutical companies to market duloxetine delayed-release capsules (Cymbalta, Eli Lilly), for the treatment of depression and other conditions. in various strengths. Companies named were Aurobindo Pharma Ltd., Dr. Reddy’s Laboratories Ltd., Lupin Ltd., Sun Pharma Global FZE, Teva Pharmaceuticals USA, and Torrent Pharmaceuticals Ltd.

New hep C drugs shift treatment plans

On December 6, FDA approved Sovaldi (sofosbuvir) tablets for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.

Sovaldi approved to treat chronic hepatitis C

FDA has approved sofosbuvir (Sovaldi, Gilead) to treat chronic hepatitis C virus (HCV) infection. According to FDA, Sovaldi is the first drug that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon.

Anti-diabetic drugs can lower cancer risk by 32%

A specific type of diabetes drug can decrease the risk of cancer in female patients with type 2 diabetes up to 32%, according to a study published in Diabetes, Obesity and Metabolism. People with type 2 diabetes have a higher rate of cancer development and recurrence compared to the general population.