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Pulse Newsletter

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

Volume 1 | Issue 7
May 1, 2019

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

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Clinical Update

Inappropriate antibiotic prescribing still rampant

A recent study has found that only 13% of antibiotic prescriptions are confirmed as appropriately prescribed. The study, published in The BMJ, analyzed antibiotic claims and medical diagnosis codes for roughly 19 million children and non- elderly adults in the U.S. The results determined that the 23% of antibiotics were being inappropriately prescribed, with an additional 36% being considered as potentially appropriate. The practice of inappropriate antibiotic prescribing is not only bad practice, but is also costly to the health care system due to the development of antibiotic resistance. According to another study published in Health Affairs, antibiotic resistance adds nearly $1,400 to the bill for treating a bacterial infection and costs the U.S. more than $2 billion annually in direct medical costs.

Safety First

FDA orders important safety labeling changes for Addyi®

The FDA has ordered Sprout Pharmaceuticals, manufacturer of Addyi® (flibanserin), a drug indicated for the treatment of hypoactive sexual desire disorder (HSDD) in postmenopausal women, to revise important safety information contained in the product labeling. Upon initial approval of Addyi® in 2015, the FDA identified cases of severe low blood pressure and instances of fainting when Addyi® and alcohol were taken together, and therefore required Sprout to reflect those risks as a boxed warning and complete further safety studies. The recent order to update labeling was initiated as a result of the FDA’s review of the postmarketing safety studies, which concluded that the risk of severe adverse side effects were not as prominently seen in long-term follow up. Therefore, the FDA has determined that changes must be made to Addyi’s® labeling to clarify that there is still a concern about consuming alcohol close in time to taking Addyi® but that it does not have to be avoided completely, as previously indicated.

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From the Industry

Artificial Intelligence (AI) could identify existing drugs to help treat Age-Related Macular Degeneration (AMD)

Initial results from a collaboration between Action Against Age-related Macular Degeneration (AMD), a strategic research initiative, and BenevolentAI, an artificial intelligence company, shows that a number of existing drugs have the potential to reduce sight loss caused by AMD, a disease that affects 196 million people worldwide. The project utilized a proprietary platform, known as the ‘Benevolent Platform,’ to conduct a comprehensive review of millions of scientific papers, clinical trials, and datasets relating to AMD. The research identified seven existing drugs that have the potential to be repurposed to treat macular degeneration, in addition to identifying new targets for investigation.

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FDA Approvals

Recent FDA Approvals

New Drug Approval: Dovato® (dolutegravir/lamivudine)
Oral tablets for the treatment of HIV-1 in adults with no HIV treatment history [4/8/19 – Priority Review – VIIV HLTHCARE]

New Drug Approval: Evenity® (romosozumab-aqqg)
Subcutaneous injection for the treatment of osteoporosis in postmenopausal women at high risk of fracture [4/9/19 – AMGEN INC]

New Drug Approval: BalversaTM (erdafitinib)
Oral tablets for the treatment of adult patients with locally advanced or metastatic bladder cancer [4/12/19 – Accelerated ApprovalBreakthrough Therapy – JANSSEN BIOTECH]

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New Generics

New Generics Entering the Marketplace

Letairis® (ambrisentan)
Indication: Pulmonary arterial hypertension (PAH)
Dosage Form/Strength: 5MG, 10MG Tablets
Average Wholesale Price (AWP): Generic = 5MG ($10,849)/10MG ($10,849 | Brand = 5MG ($11,650)/10MG ($11,650)

Triglide® (fenofibrate)
Indication: High cholesterol
Dosage Form/Strength: 160MG Tablets
Average Wholesale Price (AWP): Generic = 160MG ($71) | Brand = 160MG ($410)