RxStrategies Clinical Insights – August 2014

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    Welcome to this month’s RxStrategies Clinical Insights, a concise communication to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy market place.

    New Drug Approvals

    Cerdelga (eliglustat) – New Orphan Drug Approval

    August 19, 2014 – The U.S. Food and Drug Administration approved Cerdelga™ (eliglustat) for the long-term treatment of adult patients with the Type 1 form of Gaucher disease. Cerdelga™ (eliglustat) represents the first oral treatment approved for Gaucher’s disease. RxS Insight: Cerdelga represents a new oral drug option for Type 1 Gaucher’s and target’s the buildup of fatty deposits in cells rather than the break of the fatty deposits by traditional intravenous therapies. The drug is not appropriate for CYP2D6 ultra-rapid metabolizers. Expect the product to be limited distribution to select specialty pharmacies.  Read More.


    Plegridy ™ (peginterferon beta-1a) – New Drug Approval

    August, 15, 2014 – The U.S. Food and Drug Administration has approved Plegridy™ (peginterferon beta-1a,) as a new disease-modifying therapy for people with relapsing forms of MS. Peginterferon beta-1a, injected under the skin every two weeks, is a new therapy that belongs to the same interferon class as several medications that have been approved to treat MS. This new version is designed to maintain the effects of interferon in the body for a longer period of time. RxS Insight: Plegridy™ represents a new alternative to Avonex and Rebif. Plegridy™ does not have orphan drug status like Avonex. Read More. 


    Belsomra® (suvorexant) – New Drug Approval

    August 13, 2014 – The U.S. Food and Drug Administration approved Belsomra® (suvorexant) tablets for use as needed to treat difficulty in falling and staying asleep (insomnia). Belsomra® (suvorexant) is an orexin receptor antagonist and is the first approved drug of this type. Orexins are chemicals that are involved in regulating the sleep-wake cycle and play a role in keeping people awake. Belsomra® (suvorexant) alters the signaling action of orexin in the brain. RxS Insight:  Belsomra® should be available in Q4 2014 or Q1 2015. Belsomra® will be DEA scheduled C-IV and has the potential for abuse with other CNS depressants including alcohol.  Read More.


    Invokamet™ (canagliflozin and metformin) –New Drug Formulation Approval

    August 8, 2014 –Janssen Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) has approved Invokamet, a fixed-dose therapy combining Invokana® canagliflozin and metformin hydrochloride in a single tablet, for the treatment of adults with type 2 diabetes. Invokamet is the first fixed-dose combination of an SGLT2 inhibitor with metformin approved in the United States. Read More.  


    Orbactiv™ (oritavancin) – New Drug Approval

    August 6, 2014 – The U.S. Food and Drug Administration approved Orbactiv™ (oritavancin) a new antibacterial drug to treat adults with skin infections. Orbactiv™ (oritavancin is approved to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), various Streptococcus species and Enterococcus faecalis. Orbactiv™ (oritavancin is administered intravenously. RxS Insight: As an intravenous product the product will be limited primarily to hospital use.   Orbactiv™ represents the third new acute bacterial skin and skin structure infections (ABSSSI) drug approved as a Qualified Infectious Disease Product to receive FDA approval in 2014. Dalvance (May 2014) and Sivextro (June 2014) were approved earlier this year.  Read More.


    Jardiance® (empagliflozin) – New Drug Approval

    August 1, 2014 – The U.S. Food and Drug Administration approved Jardiance (empagliflozin) tablets as an addition to diet and exercise to improve glycemic control in adults with type 2 diabetes. Jardiance is a sodium glucose co-transporter 2 (SGLT2) inhibitor. RxS Insights: Jardiance® will provide a new alternative to the currently approved sodium glucose co-transporter 2 (SGLT2) inhibitors Invokana® (canagliflozin) and Farxiga® (dapagliflozin). Read More.  


    Striverdi® Respimat® (olodaterol) – New Drug Approval

    July 31, 2014 – The U.S. Food and Drug Administration approved Striverdi® Respimat® (olodaterol) inhalation spray to treat patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema that are experiencing airflow obstruction. RxS Insight: Striverdi® is a new highly selective once-a-day inhaled long-acting ß2-agonist (LABA) that will be an add-on drug to standard anticholinergic therapies.  Read More.  


    New Drug Indications

    Avastin® (bevacizumab) – New Indication Approval

    August 14, 2014 – The U.S. Food and Drug Administration approved a new use for Avastin® (bevacizumab) to treat patients with persistent, recurrent or late-stage (metastatic) cervical cancer. This represents the sixth indication for Avastin®. Read More. 


    Velcade® (bortezomib) – New Indication Approval

    August, 8 2014 – The Millennium the Takeda Oncology Company announced the U.S. Food and Drug Administration approved Velcade® (bortezomib) or the retreatment of adult patients with multiple myeloma (MM) who had previously responded to Velcade® therapy and relapsed at least six months following completion of prior Velcade® treatment.. Read More. 


    Drug Withdrawals

    Incivek® (telaprevir) – Market Withdrawal

    August 13, 2014 – Vertex Pharmaceuticals, Inc., announced the voluntary withdrawal of Incivek® (telaprevir). Vertex stopping U.S. sales and distribution of its Incivek®  hepatitis C treatment, whose use has been largely supplanted by the new Sovaldi drug from Gilead Sciences Inc. Read More.  


    New Drug Shortages

    August 19, 2014

    August 18, 2014

    August 15, 2014

    August 14, 2014

    August 12, 2014

    Drug Recalls

    Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution

    Aug. 13, 2014 – Baxter International Inc. announced today it is voluntarily initiating a recall in the United States of two lots of Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 5000mL (Ambu-Flex II) to the hospital/user level. The recall is being initiated due to the presence of oxidized stainless steel, garment fiber, and PVC particulate matter identified during the manufacturing process. Read More.


    Cubist Pharmaceuticals – Issued Voluntary U.S. Recall of Cubcin® (Daptomycin for Injection) 500 mg in 10 mL Single Use Vials

    August 6, 2014 – Cubist Pharmaceuticals, Inc. today it is voluntarily recalling certain lots of Cubcin®(daptomycin for injection) to the user level due to the potential presence of glass particulate matter in vials produced by a contract manufacturer. Read More.


    340B News

    A Legal Perspective on 340B Compliance – Q&A with Maureen Testoni, 
General Counsel of Safety Net Hospitals for Pharmaceutical Access (SNHPA). Pharmacy Purchasing & Products, July 2014 – Vol.11, No.7, Page2. Read More.  


    Pharmacy News

    DEA to Publish Final Rule Rescheduling Hydrocodone Combination Products

    August 21, 2014 – On August 22, 2014 the U. S. Drug Enforcement Administration (DEA) will publish in the Federal Register the Final Rule moving hydrocodone combination products (HCPs) from Schedule III to the more-restrictive Schedule II, as recommended by the Assistant Secretary for Health of the U.S. Department of Health and Human Services (HHS) and as supported by the DEA’s own evaluation of relevant data. Read More.


    Mylan Launches Generic Precedex Sedative as Hospira Sues FDA

    August 19, 2014 – Mylan, Inc, today announced it has launched dexmedetomidine hydrochloride injection, a therapeutically equivalent version of Precedex, while Hospira, Inc, has filed a lawsuit to challenge the generic approval. Read More.


    Pharmacies Turn Drugs Into Profits, Pitting Insurers vs. Compounders

    August 14, 2014 – The increase in pharmacy compounding claims is pitting Insurers vs. Pharmacies.  For example, Express Scripts, has said it will stop paying for more than 1,000 ingredients used in compounding, cutting spending by its health plan clients on such medicines by 95 percent. It said such spending had grown to $171 million in the first quarter of this year from $28 million in the first quarter of 2012. Read More.


    Office of Inspector General (OIG) Issues Unfavorable Advisory Opinion to Specialty Pharmacy for Support Service Payments

    August 15, 2014 – The OIG issued an unfavorable Advisory Opinion to a specialty pharmacy in connection with the pharmacy’s proposal to pay local retail pharmacies for support services that they provide in connection with patient referrals to the specialty pharmacy. Read More.


    Express Scripts Drops Amgen Anemia Drugs From Formulary

    August 5, 2014 – Express Scripts Holding Co, the largest U.S. pharmacy benefit manager, said it will remove an additional 25 products from its list of preferred drugs in 2015, including anemia drugs Epogen and Aranesp, sold by Amgen Inc. Read More.


    Top 100 Most Prescribed, Top-Selling Drugs

    August 1, 2014 – There has been little change in top-prescribed and top-selling prescription drugs in the United States, according to the latest data from research firm IMS Health.

    Hypothyroid medication levothyroxine (Synthroid,) continues to be the nation’s most prescribed drug, and the antipsychotic aripiprazole (Abilify) continues to have the highest sales. Read more.


    We welcome your comments and suggestions regarding additional key issues or topics you would like us to cover in the RxStrategies Clinical Insights. Contact us for more information.