FDA Update: August 2017

Aug 15, 2017
Express Scripts Office of Clinical Evaluation and Policy tracks some recent updates to the drug pipeline.

New Pill Bottle

Some of the U.S. Food and Drug (FDA) actions that were noted by the Emerging Therapeutics team last month include:

Endari Approved for Sickle Cell Disease

The FDA approved Endari™ (L-glutamine) oral powder on July 7, 2017. A replacement for an amino acid deficiency resulting from sickle cell disease, Endari is indicated to decrease complications, such as acute attacks (sickle cell crises), for patients as young as five years old. In clinical trials that lasted 48 weeks, patients taking it had fewer crises, emergency room visits and hospitalizations than patients receiving placebo. They reported less pain, as well. Endari powder is combined with eight ounces of a cold or lukewarm drink or about four ounces to six ounces of soft food, like pudding or applesauce, and then consumed right away. Recommended dosing is a total of 10Gm to 30Gm per day, based on body weight and taken in two doses. The manufacturer, Emmaus Life Sciences, Inc., has not yet announced launch or pricing plans for Endari. Complete prescribing information is available here.

Tremfya Approved for Psoriasis

On July 13, 2017, Janssen received FDA approval of Tremfya™ (guselkumab) for the treatment of adults who have moderate to severe plaque psoriasis and who are candidates for systemic treatment or phototherapy. Tremfya is a biologic in a new class of medications that inhibit interleukin (IL)-23. After the initial doses at weeks 0 and 4, it is administered every eight weeks by subcutaneous (SC) injection. It will be available through open distribution; therefore, Accredo will have access. Full prescribing information is available here.

Nerlynx Approved as Adjuvant for HER2+ Breast Cancer

Puma Biotechnology, Inc. announced on July 17, 2017, that the FDA approved Nerlynx™ (neratinib). A tyrosine kinase inhibitor (TKI), Nerlynx is an oral, once-a-day, extended adjuvant treatment for adults who have early stage HER2-overexpressed/amplified breast cancer. Intended to prevent cancer recurrence, it will be used following adjuvant treatment with Herceptin® (trastuzumab). Recommended dosing is six tablets (totaling 240mg) taken once daily for one year. To manage diarrhea associated with its use, patients are advised to take Imodium® (loperamide) for at least the first eight weeks of Nerlynx treatment. Puma plans to launch Nerlynx in September. Complete prescribing information is available here.

First Generic Approved for Renvela Tablets

The FDA approved Aurobindo Pharma Limited’s generic to Renvela® (sevelamer carbonate - Genzyme) tablets on July 17, 2017. Sevelamer carbonate is indicated to control phosphorous levels in the blood of patients as young as six years old who need dialysis to manage chronic kidney disease. The drug attaches to phosphorous, which then is eliminated from the body because sevelamer carbonate is not absorbed. The recommended initial adult dose is one or two of the 800mg tablets three times a day. Estimated sales of Renvela tablets amounted to about $1.9 billion for the 12 months that ended on May 31, 2017. The generic already has been launched. In mid-June, Aurobindo launched an A-rated generic to the oral suspension dosage form of Renvela.

Vosevi Approved for Hepatitis C

On July 18, 2017, Gilead Sciences’ Vosevi™ (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg) was FDA approved for the re-treatment of chronic hepatitis C virus (HCV) infection in adults with genotypes 1, 2, 3, 4, 5 or 6 previously treated with a regimen that includes a nonstructural protein 5A (NS5A) inhibitor, such as Daklinza™ (daclatasvir). It also is indicated for re-treating patients who have genotype 1a or 3 HCV and who previously were treated with a Sovaldi® (sofosbuvir)-containing regimen without an NS5A inhibitor. The recommended dose of Vosevi is one tablet daily for 12 weeks. Gilead launched it immediately through open distribution. Full prescribing information is available here.

Benlysta Subcutaneous Injection Approved

GlaxoSmithKline (GSK) announced the FDA approval of a new subcutaneous (SC) formulation of Benlysta® (belimumab) on July 21, 2017. It is indicated for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE). Benlysta is a biologic drug that inhibits the protein B-lymphocyte stimulator (BLyS). It has been on the market since 2011 as a one-hour intravenous (IV) infusion given at 10mg/Kg every four weeks following induction. The recommended dose for Benlysta SC is a once-weekly 200mg injection that patients are able to self-administer after training by a healthcare provider. GSK plans on launching Benlysta SC in late August. Full prescribing information is available at here.

Second Biosimilar for Remicade Launched

Merck and Samsung Bioepis released Renflexis™ (infliximab-abda) in the United States on July 24, 2017. It is the second FDA-approved biosimilar to be launched for Janssen Biotech’s tumor necrosis factor (TNF) inhibitor, Remicade® (infliximab). Pfizer/Celltrion’s biosimilar, Inflectra® (infliximab-dyyb), entered the U.S. market in November 2016. Like Remicade and Inflectra, Renflexis is FDA approved for treating ankylosing spondylitis, Crohn’s disease (for both adults and children), plaque psoriasis, psoriatic arthritis, rheumatoid arthritis (RA) and ulcerative colitis. Dosing varies by indication. A boxed warning and Medication Guide for all infliximab drugs notifies patients and prescribers about their potential to cause lymphomas or other cancers among children and teens, as well as serious infections for patients of any age who use them. The expected wholesale acquisition cost (WAC or list price) for a 100mg vial of Renflexis is $750, which is about $420 less per vial than the brand and about $200 less than Inflectra. In 2016, U.S. sales for Remicade were approximately $5 billion, according to Johnson & Johnson, Janssen’s parent company. For full prescribing information, click here.

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