Clinical Insights: June 23, 2017

    Welcome to the weekly edition of RxStrategies Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy market place.


    New Drug Approval

    Bevyxxa(betrixaban) – June 23, 2017 – The U.S. Food and Drug Administration approved betrixaban (Bevyxxa™, Portola) for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE. Read More.

    Haegarda® (C1 Esterase Inhibitor Subcutaneous [Human]) – June 22, 2017 – The U.S. Food and Drug Administration approved Haegarda, the first C1 Esterase Inhibitor (Human) for subcutaneous (under the skin) administration to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients. The subcutaneous route of administration allows for easier at-home self-injection by the patient or caregiver, once proper training is received. Read More. 

    Rituxan Hycela™ (rituximab and hyaluronidase human) – June 22, 2017 – The U.S. Food and Drug Administration granted regular approval to the combination of rituximab and hyaluronidase human (RITUXAN HYCELA, Genentech Inc.) for adult patients with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia. Read More. 

    Baxdela (delafloxacin) – June 19, 2017 – Melinta Therapeutics, announced that the U.S. Food and Drug Administration (FDA) has approved Baxdela™ (delafloxacin), indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria. Baxdela is a fluoroquinolone that exhibits activity against both gram-positive and gram-negative pathogens, including MRSA (methicillin-resistant Staphylococcus aureus), and is available in both intravenous (IV) and oral formulations. Read More.

    Cotempla XR-ODT (methylphenidate) – June 19, 2017 – Neos Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) approved Cotempla XR-ODT, the first and only methylphenidate extended-release orally disintegrating tablet for the treatment of attention-deficit/hyperactivity disorder (ADHD) in patients 6 to 17 years old. Read More.

    New Indication Approval

    Darzalex® (daratumumab) – June 16, 2017 – Janssen Biotech, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the immunotherapy Darzalex® (daratumumab) in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide (an immunomodulatory agent) and a proteasome inhibitor (PI). Read More. 

    Dysport® (abobotulinumtoxinA) – June 16, 2017 – Ipsen Biopharmaceuticals, Inc., announced that the U.S. Food and Drug Administration (FDA) has expanded the approved use of Dysport® (abobotulinumtoxinA) for injection for the treatment of spasticity in adults, based on its supplemental Biologics License Application (sBLA) in lower limb spasticity. In July 2015, Dysport® was approved for the treatment of upper limb spasticity in adults. In July 2016, Dysport® was approved to treat pediatric patients with lower limb spasticity aged two and older, making it the first and only botulinum toxin that the FDA approved for this indication. Read More.

    Tafinlar® (dabrafenib) + Mekinist® (trametinib) – June 22, 2017 – The U.S. Food and Drug Administration granted regular approvals to dabrafenib and trametinib (TAFINLAR® and MEKINIST®, Novartis Pharmaceuticals Inc.) administered in combination for patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. Read More. 

    New Drug Recall Alert

    Potassium Phosphate and Succinylcholine – June 22, 2017 – Advanced Pharma, Inc. d/b/a Avella of Houston is conducting a limited, voluntary recall due to Hospira Inc.’s June 15, 2017 recall announcementthat microbial growth was detected during a routine simulation of the manufacturing process and therefore there was a lack of sterility assurance. Read More. 

    Clindamycin Injection ADD-Vantage Vials – June 16, 2017 – Alvogen is voluntarily recalling seven lots of Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the product. Clindamycin Injection is manufactured for Alvogen by Hospira Inc., a Pfizer Company. Read More. 

    Clinical and Pharmacy News

    Pharmacy Outlook for Independent Pharmacies & Collaborative Practice – June 22, 2017 – Over the next five years, there appears to be a great opportunity for pharmacies and drug stores. Industry revenue is forecast to rise at an annualized rate of 5.7% to $393.1 billion, according to market research. With the shortage of primary physicians, pharmacists have an opportunity to play a pivotal role in health care by providing preventative care services, also known as point of care testing. Profit is expected to rise from 4.9% of industry revenue in 2017 to 5.9% in 2022. Read More. 

    Health Care Providers Could Prevent Opioid-Related Deaths by Testing for Certain Genes, Scientists Claim – June 22, 2017 – A review published in Clinical Chemistry has identified 10 genes that show promise in predicting how patients will respond to opioid pain medications. Using these genetic markers, health care providers could potentially tailor opioid therapy better to curb the skyrocketing rate of deaths from these drugs, the authors claim. Read More. 

    FDA Working to Lift Barriers to Generic Drug Competition – June 21, 2017 – Too many patients are being priced out of the medicines they need. While FDA doesn’t have a direct role in drug pricing, we can take steps to help address this problem by facilitating increased competition in the market for prescription drugs through the approval of lower-cost, generic medicines. Read More. 

    New York Times Obtains Copy of Draft Executive Order on Drug Prices; FDA Blogs that it is Working to Lift Barriers to Generic Drug Competition – June 20, 2017 – On June 20, 2017, the New York Times reported that it had obtained a draft proposal of President Trump’s Executive Order on drug prices. The draft Executive Order, which has not been published, has been characterized as focusing on rolling back regulations, with the New York Times reporting that the Executive Order strengthens the pharmaceutical industry’s monopoly power overseas and scales back the federal 340B program, a program that allows hospital and clinics that serve low-income populations to receive discounts on drugs from pharmaceutical companies. Read More.

    Draft Order on Drug Prices Proposes Easing Regulations – June 20, 2017 – In the early days of his administration, President Trump did not hesitate to bash the drug industry. But a draft of an executive order on drug prices appears to give the pharmaceutical industry much of what it has asked for — and no guarantee that costs to consumers will drop. Read More. 

    Exclusive: White House Task Force Echoes Pharma Proposals – June 16, 2017 – President Donald Trump repeatedly talks tough about reining in the pharmaceutical industry, but his administration’s efforts to lower drug prices are shrouded in secrecy. Read More. 

    340B in the News

    Draft Drug Price Order Focuses on Regulations, Trade – June 23, 2017 – The Trump administration might seek to roll back regulations in pursuit of faster drug approvals, promoting drug competition and new payment models for federal health insurance programs, according to a draft executive order obtained by CQ Roll Call. Read More.

    Patients Can Take Steps to Lower Prescription Costs – June 21, 2017 – Nobody needs to be told that prescription drug bills can consume large fractions of household incomes. But in recent years, some momentum has picked up among the public and within the government to put some sort of downward pressure on the ever-rising prices. Read More. 

    4 things to Know About Trump’s Executive Order on Drug Pricing – June 21, 2017 – A draft of President Donald Trump’s executive order on drug prices lists several proposals to roll back regulatory hurdles for the pharmaceutical industry, reports The New York Times. Here are four things to know about the proposals. Read More. 

    Leah Ralph on the Political and Legal Obstacles to 340B Reform – June 20, 2017 – The uncertainty in the political climate, along with the limited authority of the Health Resources and Services Administration (HRSA) within HHS, makes it difficult to predict whether the 340B program will be reformed in coming years, according to Leah Ralph, director of health policy at the Association of Community Cancer Centers. Read More. 

    Congress Asking Questions About Lucrative Drug Discount Program – June 19 2017 – A federal drug discount program that is worth millions to Georgia hospitals is facing new scrutiny in Washington. The U.S. House Committee on Energy and Commerce, which oversees health issues, this month expressed concerns about the little-known “340B” program and requested documents from the agency that oversees the program. Read More. 

    Doctor: Hospital Using Federal Program to Undercut Our Price – June 18, 2017 – An independent fertility doctor says the University of Vermont Medical Center is abusing a federal program designed for low-income people in a way that could put her practice out of business. Dr. Christine Murray left a high-level position at the hospital in 2014 to co-found Northeastern Reproductive Medicine in Colchester. Within five days of opening, the hospital hit her and her business partner with a lawsuit that she considers frivolous, but the hospital defends. Read More.