FDA Update: December 2016

Dec 22, 2016
Express Scripts Office of Clinical Evaluation and Policy tracks some recent updates to the drug pipeline.
  • Mental/Neurological Disorders
  • Inflammatory Conditions
  • Cancer
  • Diabetes

New Pill Bottle

Express Scripts’ Emerging Therapeutics team focused on several U.S. Food and Drug Administration (FDA) approvals for new drugs, generics and indications:

Generics to Seroquel XR Launched

Par Pharmaceutical, an operating company of Endo Pharmaceuticals, began shipping four strengths of quetiapine extended-release tablets to U. S. wholesalers on Nov. 1, 2016. Par’s generics are AB-rated to AstraZeneca’s Seroquel XR®, a once-daily atypical antipsychotic that is indicated for bipolar disorders, depression, mania and schizophrenia. As the result of a settlement agreement, Par is launching one year before the Seroquel XR patent expires. It has 180-days of exclusivity for the 50mg, 150mg, 200mg and 300mg tablet strengths. A separate agreement let Accord Healthcare, Inc. launch the 400mg strength generic on November 1, as well.

New Indication for Enbrel

On Nov. 4, 2016, Amgen announced that a new indication was FDA approved for Enbrel® (etanercept) injection. A tumor necrosis factor (TNF) inhibitor, it was first FDA approved in 1998 for treating adults who have rheumatoid arthritis (RA). Six years later, it received an indication to treat adults with moderate-to-severe plaque psoriasis. Now, Enbrel is the first biological anti-inflammatory drug indicated to treat moderate-to-severe chronic plaque psoriasis among teens and children as young as four years of age. Enbrel dosing for patients between four and 17 years of age is based on their weight at 0.8mg/Kg/week injected subcutaneously (SQ), with a weekly limit of 50mg. Enbrel’s labeling carries a boxed warning that using it may be associated with severe infections and that patients should be checked for tuberculosis (TB) before beginning it, while undergoing therapy and for several months after Enbrel treatment ends. All recommended vaccinations should be given before treatment with it starts. Additionally, some children and teens who used Enbrel or drugs like it developed lymphoma or other forms of cancer. Updated full prescribing information for Enbrel can be found here.

Vemlidy Approved for Hepatitis B

Vemlidy® (tenofovir alafenamide – Gilead Sciences, Inc.) was approved by the FDA on Nov. 10, 2016. It is indicated to treat patients who have chronic hepatitis B and compensated (not yet progressed to cirrhosis) liver disease. Because Vemlidy maintains relatively constant blood levels, it is effective at a lower dose (25mg/day) than Gilead’s previous hepatitis B drug, Viread® (tenofovir disoproxil fumarate), which is dosed at 300mg/day. Consequently, Vemlidy does not cause as many side effects, particularly on bones and in kidneys, as Viread does. However, labeling for Vemlidy does include a boxed warning that taking it may be associated with two potentially serious conditions – lactic acidosis (excessive lactate accumulation) and hepatomegaly with steatosis (enlargement of the liver with fat deposits). In addition, hepatitis B may reactivate after treatment with Vemlidy ends. Recommended dosing is one tablet daily along with a meal or snack. Vemlidy launched through open distribution on Nov. 11, 2016, with a wholesale price comparable to Viread’s  ̶  approximately $1,000 for a 30-day supply. Complete prescribing information is available here.

Opdivo Gains New Indication

Bristol-Myers Squibb received a new indication for its programmed death receptor-1 (PD-1) checkpoint inhibitor, Opdivo® (nivolumab) injection for intravenous (IV) use. On Nov. 10, 2016, the monoclonal antibody was approved to treat patients who have squamous cell carcinoma of the head and neck (SCCHN) that has spread or come back despite prior or concurrent treatment with a platinum-based chemotherapy drug. As an immunotherapy agent, it enhances the ability of the immune system to attack and destroy cancer cells. In the clinical trial, CheckMate-14, the average overall survival rate was about 7.5 months for Opdivo-treated patients compared to about 5.1 months for patients treated with other standard drugs. For SCCHN, Opdivo is given once every two weeks through a 60-minute IV infusion that contains 3mg of drug for each Kg the patient weighs. Originally FDA approved Opdivo in December 2014 as a breakthrough therapy for advanced melanoma, it also has several additional indications, both alone and in combination with other drugs, to treat various types of cancer. Prescribing information can be found here.

Soliqua and Xultophy Approved for Type 2 Diabetes

The FDA simultaneously approved Sanofi’s and Novo Nordisk’s fixed-dose long-acting insulin and glucagon-like peptide 1 (GLP-1) agonist combination products for treating type 2 diabetes on Nov. 21, 2016. Soliqua, from Sanofi, combinesLantus® (insulin glargine) and Adlyxin® (lixisenatide). Novo Nordisk’s Xultophy® combines Tresiba® (insulin degludec) and Victoza® (liraglutide). Both products are dosed once daily by SQ injection. Soliqua will be available to U.S. retail pharmacies in January 2017; Xultophy’s launch will occur in the first half of 2017.

Soliqua prescribing information can be found here. Xultophy prescribing information is available here.

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