Formulary Watch |

Faster FDA approvals lead to cancer drug boom

The Food and Drug Administration (FDA) is approving new drugs – especially those to treat cancer – at a near record pace this year.

FDA approves DTaP-IPV combo vaccine for children ages 4 to 6

FDA has approved use of Diphtheria and Tetanus Toxoids and Acellular Pertussis Absorbed and Inactivated Poliovirus; DTaP-IPV (Quadracel, Sanofi Pasteur, the vaccines division of Sanofi) vaccine for active immunization against diphtheria, tetanus, pertussis and poliomyelitis in children aged 4 through 6 years.

Study: Medication effectiveness diminishes when patients crush tablets

People who take more than 4 doses of medicine a day appear more likely to crush tablets or open capsules potentially reducing their effectiveness, according to a study published in the Journal of Pharmacy Practice and Research.

New HHS plan on opioids ups naloxone use

Health and Human Services (HHS) recently launched a widespread initiative – including increasing the use of naloxone to reverse opioid overdoses – aimed at reducing prescription opioid and heroin related overdose, death and dependence.

Tanezumab clinical trials to resume

Pfizer and Eli Lilly and Company said they will resume Phase 3 clinical studies for tanezumab for chronic pain, after the Food and Drug Administration (FDA) lifted a partial hold on trials.

FDA warns about serious reactions to Harvoni, Sovaldi

Both the Food and Drug Administration (FDA) and Harvoni and Sovaldi maker Gilead are warning Hepatitis C patients about serious bradycardia when the drugs are combined with certain other medications.

Treatment for inhalational anthrax approved

FDA has approved Anthrax Immune Globulin Intravenous (Human) (Anthrasil, Emergent BioSolutions) also known as AIGIV, for treatment of inhalational anthrax in combination with appropriate antibacterial drugs.

Letter details pediatric antipsychotic medication problems

Restrictive Medicaid prior authorization policies are leading to substitution of potentially inappropriate, off-label psychotropic medication use and other problems in prescribing antipsychotic medications for children, according to a recent research letter.

Tiotropium improved asthma symptoms in phase 3 trials

New data from Phase III trials showed that the addition of tiotropium Respimat in adult patients with mild, moderate and severe asthma who continue to experience symptoms despite the use of maintenance therapies improved lung function. Boehringer Ingelheim recently presented the new data on investigational tiotropium delivered via Respimat® inhaler at the 2015 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Houston, Texas.

FDA expanded approval of aflibercept injection to treat diabetic retinopathy

FDA has expanded the approval of aflibercept (Eylea, Regeneron) injection to treat diabetic retinopathy in patients with macular edema.

DME study: Aflibercept injection shows greater gains in visual acuity than alternative anti-VEGF therapies

In patients with moderate or worse vision loss at baseline, those treated with aflibercept (Eylea, Regeneron) Injection gained, on average, an additional full line or more on an eye chart when compared to those treated with alternative anti-VEGF therapies, according to a study published in the New England Journal of Medicine.

Drugs in Perspective: Opdivo (nivolumab)

On December 22, 2014, Opdivo (nivolumab) was approved by FDA with a breakthrough therapy designation. Nivolumab is the second human programmed death-1 (PD-1) receptor-blocking antibody to gain accelerated approval for treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor.

Hepatitis C therapies, compounded meds drive increase in US drug spending

New hepatitis C therapies with high price tags and the exploitation of loopholes for compounded medications drove a 13.1% increase in US drug spending in 2014 – a rate not seen in more than a decade, according to Express Scripts 2014 Drug Trend Report.

ACC: NVAF patients at high risk for stroke may be undertreated

Many nonvalvular atrial fibrillation (NVAF) patients at high risk for stroke may be undertreated, according to poster presentation sessions at the American College of Cardiology (ACC) 64th Annual Scientific Session in San Diego, Calif.

Study: 4F-PCC may be beneficial over plasma in patients needing warfarin reversal for urgent surgical, invasive procedures

Pharmacy stakeholders support controlled substances document

A coalition of stakeholder organizations – including the American Pharmacists Association (APhA), the National Association of Chain Drug Stores (NACDS) and the National Community Pharmacists Association (NCPA) – released a consensus document on the "red flag" warning signs related to prescribing and dispensing controlled substance prescriptions.

FDA panels approve Breo Ellipta for asthma in adults, not kids

Food and Drug Administration (FDA) committees this week voted to approve GlaxoSmithKline and Theravance’s Breo ELlipta (fluticasone furoate/vilanterol) as an asthma treatment for adults 19 years and older, but not for 12 to 17-year-olds.

FDA warns consumers about OTC homeopathic asthma treatments

The FDA warns consumers not to rely on the use of over-the-counter homeopathic therapies for the treatment of asthma. Without appropriate management, asthma could lead to a life-threatening asthma attack. Homeopathic remedies have not be evaluated by the FDA and may interfere with asthma management.

[BLOG]: FDA approves first biosimilar in US, may lead to easier access to biologic medications for patients

In this guest blog post, Larry LaMotte, spokesperson for Patients for Biologics Safety & Access and Vice President of Public Policy at the Immune Deficiency Foundation, discusses the possibility of biosimilars helping increase access to vital medications for patients with chronic and life-threatening conditions.

New dose of Viibryd approved to treat major depressive disorder in adults

FDA has approved a new dose of vilazodone (Viibryd, Actavis) for the treatment of Major Depressive Disorder (MDD) in adults.

Study: Genetic variants determine whether aspirin/NSAIDS will reduce colorectal cancer risk

Regular use of aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) appears to reduce the risk of colorectal cancer in most individuals, but a few individuals with rare genetic variants do not share this benefit, according to a study published in the March 17 issue of JAMA.

[BLOG]: Best Practices between formulary managers and pharmacists to address challenges in COPD readmissions

To address the burden of COPD on hospital expenditures, on October 1, 2014, the Centers for Medicare & Medicaid Services included COPD in its Hospital Readmissions Reductions Program. This inclusion resulted in reduced Medicare reimbursement for hospitals that demonstrate excessive 30-day COPD patient readmission rates.

FDA approves drug to treat rare bile acid synthesis disorders in kids, adults

FDA approved its first treatment for pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders (including Zellweger spectrum disorders).

DEA issues alert on fentanyl after overdoses

The United States Drug Enforcement Administration (DEA) on March 18 issued a nationwide alert about the dangers of fentanyl and fentanyl analogues/compounds.

Drugs in Perspective: Lemtrada (alemtuzumab)

Lemtrada (alemtuzumab) received FDA approval on November 14, 2014, under fast track designation, for the treatment of patients with relapsing forms of MS.Due to the safety profile, alemtuzumab should generally be reserved for patients who have had an inadequate response to 2 or more drugs indicated for MS.

First atypical antipsychotic approved for pediatric patients with bipolar I disorder in 5 years

FDA has approved asenapine (Saphris, Actavis) for treatment of manic or mixed episodes of bipolar I disorder in pediatric patients, ages 10 to 17 years old.

Investigational PCSK9 inhibitor lowers LDL-C, may reduce cardiovascular events

Alirocumab (Praluent), a PCSK9 inhibitor, reduced low-density lipoprotein (LDL) cholesterol levels in patients who are receiving statin therapy, according to a study published online in the New England Journal of Medicine.

GAO: Antipsychotic overuse “widespread” for dementia

There is widespread overuse of psychiatric drugs by older Americans with Alzheimer’s disease or dementia who live at home or in assisted living facilities, according to a new General Accountability Office (GAO) report.

Takeda announces post hoc analysis of data from EXAMINE cardiovascular safety outcomes trial

In patients with type 2 diabetes and recent acute coronary syndrome (ACS), dipeptidyl peptidase 4 (DPP-4) inhibitor alogliptin compared to placebo did not increase the risk of heart failure (HF) outcomes, according to data published in The Lancet.

IPF survival rates better in double-lung transplantation

Double-lung transplantation in patients with idiopathic pulmonary fibrosis (IPF) and chronic obstructive pulmonary disease (COPD) was associated with better graft survival and patient survival than single-lung transplantation, according to a JAMA study.