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Pulse Newsletter

Your source for the latest industry trends and drug information news.

Volume 1 | Issue 11
July 1, 2019

Chief Author: Kevin Lavery, PharmD
Editor: Dana Ranallo, PharmD

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Clinical Update

FDA approves new treatment for pediatric patients with type 2 diabetes

On June 17, 2019, the U.S. FDA announced the approval of Victoza® (liraglutide) injection for the treatment of pediatric patients 10 years or older with type 2 diabetes. Victoza® belongs to a class of diabetes medications known as glucagon-like peptide-1 (GLP-1) receptor agonists that work by slowing digestion and stimulating the pancreas to produce more insulin when needed. Victoza® is the first non-insulin drug approved to treat type 2 diabetes in pediatric patients since metformin was approved for pediatric use in 2000. Victoza® was first approved in 2010 to treat adult patients with type 2 diabetes. According to the U.S. Centers for Disease Control and Prevention (CDC) Diabetes Report Card, there are more than 5,000 new cases of type 2 diabetes diagnosed each year in the U.S. in those aged 20 and younger.

Safety First

Measles vaccine injury claims are rare, according to new analysis

A new analysis of the National Vaccine Injury Compensation Program conducted by the New York Times reveals injury claims filed due to the measles vaccine are rare, despite growing vaccine hesitancy from some communities across the country. Data from the federal program indicate that about 126 million doses of measles vaccinations have been administered in the past 12 years in the U.S. and 284 people filed claims of harm from those immunizations. This equates to about two claims of harm for every million doses of the vaccine administered. In contrast, one of every four people who get measles are likely to be hospitalized for complications of the disease. As of June 13th, there have been 1,044 cases of measles confirmed in 28 states in 2019, which is the greatest number of cases reported in the U.S. since 1992 according to the CDC. The CDC also notes that, in any given year, more measles cases can occur due to an increase in the number of travelers who get measles abroad and bring it into the U.S. upon their return.

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From the Industry

Experimental drug may delay onset of Type 1 diabetes in individuals at high risk for the disease

Results from a new study published in The New England Journal of Medicine, showed that the onset of type 1 diabetes could be delayed with an experimental drug known as teplizumab. The randomized trial involved relatives of patients with type 1 diabetes who did not have diabetes but were at high risk for developing the disease. The researchers randomly assigned patients to a 14-day course of teplizumab or placebo and followed them for progression to type 1 diabetes in 6-month intervals. The average time to diagnosis of type 1 diabetes was 48.4 months in the teplizumab group and 24.4 months in the placebo group. This is the first trial to show that this class of medication has the potential to delay type 1 diabetes progression in high-risk patients.

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FDA Approvals

Recent FDA Approvals

Novel Drug Approval: Polivy™ (polatuzumab vedotin-piiq)
Intravenous infusion for the treatment of adult patients with a type of lymph node cancer known as diffuse large B-cell lymphoma (DLBCL) [6/10/2019 – Accelerated ApprovalBreakthrough TherapyOrphan DrugPriority Review – GENENTECH]

New Formulation: budesonide ER capsules - 6mg, 9mg
Intravenous infusion for the treatment of gastric and breast cancer [6/13/19 – AMGEN INC]

New Biosimilar: Kanjinti™ (trastuzumab-anns)
Oral tablets to be used in combination with fulvestrant for the treatment of breast cancer [5/24/19 – Priority Review – NOVARTIS PHARMS CORP]

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New Generics

New Generics Entering the Marketplace

Revatio® (sildenafil)
Indication: Pulmonary Arterial Hypertension (PAH)
Dosage Form/Strength: 10MG/ML Suspension
Average Wholesale Price (AWP): Generic = 10MG/ML ($14,296) | Brand = 10MG/ML ($15,885)

Naftin® (naftifine hydrochloride)
Indication: Fungal infection
Dosage Form/Strength: 1% Gel
Average Wholesale Price (AWP): Generic = 1% ($472) | Brand = 1% ($497)