Formulary Watch |

$125-million priority review voucher drug sale sets benchmark

Pharmaceutical manufacturers got a better idea of the value of FDA’s Priority Review Vouchers (PRVs) recently after Gilead Sciences paid $125 million in cash for Knight Therapeutics’ Neglected Tropical Disease PRV.

ACR: Lesinurad as a combo therapy with allopurinol may be effective in treating gout

Data from 2 phase 3 studies of lesinurad in combination with allopurinol in gout patients was presented at the American College of Rheumatology (ACR) 2014 annual meeting in Boston.

Drugs in Perspective: Myalept (metreleptin)

Myalept (metreleptin) is a leptin analogue with the same physiologic effects as leptin.11 Metreleptin was granted a priority review and was FDA approved on February 25, 2014, as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired lipodystrophy.

FDA reviews trial results of long-term dual antiplatelet therapy

FDA announced that it will review results from a clinical trial showing that long-term dual antiplatelet therapy decreased the risk of heart attacks and clot formation in stents, but there was an increased overall risk of death compared to 12 months of treatment.

Study: Investigational drug may change course of patients’ heart failure

Investigational drug LCZ696 (Novartis), an angiotensin receptor neprilysin inhibitor (ARNI), is superior to angiotensin-converting enzyme (ACE) inhibitor alone in reducing the risks of death and of hospitalization for heart failure, according to data presented at the American Heart Association's (AHA) Scientific Sessions in Chicago.

Coalition promotes important acetaminophen dosing reminders

It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.

Dabrafenib-trametinib combo linked to improved overall survival in melanoma patients compared to vemurafenib monotherapy

Treatment with the combination of trametinib (Mekinist) and dabrafenib (Tafinlar) significantly improved overall survival (OS) compared to vemurafenib monotherapy in previously untreated patients with BRAF V600E/K mutation-positive metastatic melanoma, without increased overall toxicity, according to a study published in the New England Journal of Medicine.

New drug approved by FDA for the treatment of relapsing MS

FDA has approved alemtuzumab (Lemtrada, Genzyme, A Sanofi Company) for the treatment of patients with relapsing forms of multiple sclerosis (MS).

Cirrhosis patients benefit from new hepatitis C drug

The new combination hepatitis C drug ledipasvir/sofosbuvir (Harvoni, Gilead Sciences) has been found to be highly effective in treating patients with cirrhosis who have not benefited from previous therapies.

FDA concerned about generic ADHD drugs

FDA has warned about 2 approved generic versions of Concerta tablets to treat attention-deficit hyperactivity disorder (ADHD).

Patients who think they are allergic to penicillin probably are not

Many people who report an allergy to penicillin actually are not allergic to penicillin, according to a study presented at the American College of Allergy, Asthma and Immunology (ACAAI) Annual Scientific Meeting, in Atlanta.

Compounding may not be best option during saline shortage

The shortage of saline solution among hospitals is ongoing and doesn’t appear to be resolving anytime soon, according to a quality executive with the American Society of Health-System Pharmacists (ASHP). In addition, safety concerns make it prohibitive for hospitals to compound their own solutions.

Newly approved blood test predicts organ transplant rejection in children

FDA has approved a first-of-its-kind, personalized blood test to predict the likelihood of organ rejection in children with liver or intestine transplants (Pleximmune). The test was developed by researchers at Children’s Hospital of Pittsburgh of UPMC to determine a personalized rejection-risk index with cell-based technology.

FDA approves Cyramza in combination with paclitaxel for advanced gastric cancer after prior chemotherapy

FDA has approved ramucirumab (Cyramza, Eli Lilly) in combination with paclitaxel (a type of chemotherapy) as a treatment for people with advanced or metastatic gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy.

FDA analysis of dabigatran versus warfarin for nonvalvular AF questioned

A new study has found a greater bleeding risk associated with the use of dabigatran (Pradaxa, Boehringer Ingelheim) in patients with nonvalvular atrial fibrillation (AF) than that cited on initial FDA approval of the drug.

Olysio indication expanded for combo use with Sovaldi in hepatitis C

FDA has approved simeprevir (Olysio, Janssen) in combination with sofosbuvir (Sovaldi, Gilead) as an oral, interferon- and ribavirin-free treatment option for genotype 1 chronic hepatitis infection in adults.

Cholesterol-lowering agent leads list of most-prescribed drugs

Rosuvastatin (Crestor, AstraZeneca), a cholesterol-lowering agent, is currently the most-prescribed drug among the 100 most-prescribed and best-selling drugs in the United States. In the past 12 months, new prescriptions and refills for rosuvastatin have been estimated to amount to 23.7 million.

Risk of exacerbations of COPD not increased in patients discontinuing inhaled glucocorticoids

The risk of moderate or severe exacerbations in patients with severe but stable chronic obstructive pulmonary disease (COPD) who receive tiotropium plus salmeterol has been found to be similar among subjects discontinuing inhaled glucocorticoids and subjects continuing their use. Nevertheless, in making decisions about maintenance therapy for these patients the effect of withdrawal of glucocorticoids on their symptoms and pulmonary function should be carefully considered.

Specialty drug spending up considerably, but reforms limit out-of-pocket burden

Specialty drug spending per user has increased considerably in recent years, but still represents a small portion of overall drug spending per beneficiary, according to a study published recently in Health Affairs.

Drugs in Perspective: Otezla (apremilast)

Otezla (apremilast), a small-molecule inhibitor of phosphodiesterase 4 (PDE4), was approved by FDA on March 21, 2014, for the treatment of adult patients with active psoriatic arthritis. On September 23, 2014, it was approved for a second indication, the treatment of patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy

Flublok influenza vaccine now approved for adults 18 and older

FDA has approved Flublok (Protein Sciences) recombinant influenza vaccine for all adults aged 18 years and older. Previously, Flublok was indicated for adults aged 18 to 49 years.

FDA drug approvals-November 2014

FDA drug approvals, fast-track designations

FDA approves combo pill for adults with type 2 diabetes

FDA has approved once-daily dapagliflozin and metformin hydrochloride extended-release (Xigduo, AstraZeneca) (XR) for the treatment of adults with type 2 diabetes. Xigduo XR is indicated as an adjunct therapy to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.

Ibuprofen safe, effective in children discharged home with bone fractures

In children discharged home with a fracture, both ibuprofen and oral morphine were effective at relieving pain. However, there were no significant differences in efficacy between the 2 agents and oral morphine was associated with more side effects, according to a study published in the Canadian Medical Association Journal.

FDA: Limit use of anticoagulant edoxaban

FDA advisors have recommended approval of a 60-mg dose of edoxaban (Daiichi Sankyo), a once-daily anticoagulant that inhibits Factor Xa, for some atrial fibrillation patients, but suggested limiting its use to those with abnormal kidney function.

FDA approves first vaccine for preventing serogroup B meningococcal disease

Meningococcal group B vaccine (Trumenba, Pfizer) has been granted accelerated approval by FDA as the first vaccine licensed in the United States for active immunization to prevent invasive meningococcal B disease from Neisseria meningitidis serogroup B.

New antiarrhythmic agent gets FDA approval

FDA has approved sotalol hydrochloride oral solution (Sotylize, Arbor Pharamceuticals) for the treatment of documented life-threatening ventricular arrhythmias and the maintenance of normal sinus rhythm in patients with a history of highly symptomatic atrial fibrillation/flutter.

[BLOG]: How to position your hospital pharmacy as a strategic asset

Hospital pharmacies play an essential role in the nation’s healthcare system, and these days, are expected to add value to every aspect of a hospital's strategic agenda.

Ebola clinical activity heats up with vaccine candidates in works

The Ebola outbreak has taught us that the health systems in West Africa are under-resourced and vulnerable. Scaling up capability of local healthcare provision is an important consideration for control of this virus, and drug makers are gearing up to expedite development of Ebola vaccines.

FDA approves Obizur for acquired hemophilia A

FDA has approved Antihemophilic Factor (Recombinant), Porcine Sequence] (Obizur, Baxter) for the treatment of bleeding episodes in adults with acquired hemophilia A.