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Pulse Newsletter

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

Volume 1 | Issue 16
September 15, 2019

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

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Clinical Update

Novel therapy for rare joint tumor receives FDA approval

On Aug. 2, 2019, the U.S. Food and Drug Administration (FDA) approved Turalio™ (pexidartinib) capsules as the first treatment for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with significant functional limitations. TGCT is a rare tumor that affects the thin layer of tissue covering the surfaces of joint spaces and tendons, which can ultimately lead to damage of the surrounding joint tissue and cause debilitating symptoms, such as severe pain and limitation of movement. The medication works to inhibit tumor cells from multiplying, reduces tumor size, decreases joint inflammation, and provides a new alternative to patients who are either not eligible for surgery or who have experienced limited benefits from surgical intervention. The FDA granted Turalio™ Breakthrough TherapyPriority Review, and Orphan Drug designations.

Safety First

FDA review finds no increased risk of prostate cancer with specific Parkinson’s disease medicine

In March 2010, the FDA released a Drug Safety Communication informing the public that they were aware of clinical trial data that suggested a possible increased risk of prostate cancer associated with the entacapone component of a Parkinson’s medication, Stalevo® (entacapone/carbidopa/levodopa). In addition to conducting an internal independent analysis, the FDA required the manufacturer to conduct an additional study to evaluate the potential risk. On Aug.13, 2019, the FDA released a follow up Drug Safety Communication notifying the public that their internal review of the additional data found that use of entacapone was not associated with an increased risk of prostate cancer. As a result of the review, the FDA has decided to uphold their recommendations for use of entacapone containing products as outlined in the prescribing information with no additional safety labeling required.

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From the Industry

Breztri Aerosphere® meets primary endpoint in COPD trial, according to manufacturer

On Aug. 28, 2019, AstraZeneca announced that its phase III chronic obstructive pulmonary disease (COPD) trial involving a triple- combination therapy inhaler known as Breztri Aerosphere® (budesonide/glycopyrronium/formoterol) achieved positive results. In the phase III clinical trial involving more than 8,500 participants with moderate to severe COPD, Breztri Aerosphere® met the primary endpoint of a reduction in the rate of moderate or severe exacerbations compared to two dual therapies (glycopyrronium/formoterol and budesonide/formoterol). COPD is one of the leading causes of death in the United States, and is estimated to affect more than 30 million Americans, according to the COPD Foundation.

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FDA Approvals

Recent FDA Approvals

Novel Drug Approval: Inrebic® (fedratinib)
Oral capsules indicated for the treatment of adult patients with certain types of myelofibrosis, a type of cancer that affects the bone marrow [8/16/2019 – Orphan DrugPriority Review – IMPACT BIOMEDICINES INC]

Novel Drug Approval: Rinvoq™ (upadacitinib)
Oral tablets for the treatment of adult patients with rheumatoid arthritis that have not responded to methotrexate therapy [8/16/2019 – Priority Review – ABBVIE INC]

Novel Drug Approval: Xenleta™ (lefamulin)
Oral tablets for the treatment of community-acquired bacterial pneumonia (CAP) [8/19/2019 – Priority ReviewQualified Infectious Disease Product – NABRIVA THERAPEUTICS US INC]

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New Generics

New Generics Entering the Marketplace

Dyrenium® (triamterene)
Indication: Fluid buildup/high blood pressure
Dosage Form/Strength: 50MG, 100MG Capsule
Average Wholesale Price (AWP): Generic = 50MG, 100MG ($716) | Brand = 50MG, 100MG ($796)

EpiPen Jr® (epinephrine injection, USP)
Indication: Severe allergic reaction
Dosage Form/Strength: 0.15MG/0.3ML Injection
Average Wholesale Price (AWP): Generic = 0.15MG/0.3ML ($347) | Brand = 0.15MG/0.3ML ($365)