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Pulse Newsletter

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

Volume 5 | Issue 5
March 15, 2023

Chief Authors: Rebecca Waite, PharmD, Bonnie Broczkowski, PharmD & Colleen Peehler, PharmD
Contributing Authors: Yi (Eve) Zheng, PharmD/MBA Candidate, Gabrielle Graca, PharmD/MBA Candidate

Clinical Pharmacy Update

Approval of SkyClarys® for Treatment of Friedreich’s Ataxia

On February 28, 2023, the U.S. Food and Drug Administration (FDA) approved the first treatment for Friedreich’s ataxia. Friedreich’s ataxia is a very rare, inherited and debilitating disease caused by a genetic mutation, resulting in abnormal production of a protein called frataxin. Defective or missing fraxatin can lead to oxidative stress that damages cells in the nervous system, causing them to not signal properly. Sufferers experience losses in balance, coordination and muscle strength. Initially diagnosed during adolescence, the disease worsens gradually over time and can also lead to complications such as heart disease and diabetes. Skyclarys® (omaveloxolone) capsules are approved for the treatment of Friedreich’s ataxia in adults and adolescents 16 years and older. The exact mechanism of how Skyclarys® works is unclear, but it has been shown to activate the pathway involved in cellular response to oxidative stress. Skyclarys® was found to be effective and safe to treat Friedreich’s ataxia in a 48-week randomized, placebo-controlled, double-blind study. Part 2 of the MOXie study enrolled 103 individuals with Friedreich’s ataxia who were randomized to receive either placebo or Skyclarys® 150 mg for 48 weeks. The primary objective was to assess the change in disease progression compared to placebo at week 48. Patients receiving Skyclarys® demonstrated a slower decline in functioning compared to those receiving placebo. After the study was completed, participants could continue treatment with Skyclarys® in an extension study for up to three years. Those who continued with treatment performed better clinically compared to a matched set of untreated patients. The most common side effects noted during the study were elevated liver enzymes, headache, nausea and fatigue. Skyclarys® received orphan drug, fast track, priority review and rare pediatric disease designations from the FDA. Skyclarys® is expected to be available in the second quarter of 2023 through an integrated specialty pharmacy and patient service program developed by the manufacturer. 

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Drug Safety

Recall Announced for One Batch of Over-The -Counter Eye Ointment

On February 24, 2023, the FDA announced Global Pharma Healthcare’s voluntary recall of Delsam Pharma Artificial Eye Ointment, a product used to lubricate and relieve dryness of the eyes. The recall of one batch of this product, Batch No. H29, is due to possible microbial contamination which could lead to an eye infection. This product may be additionally compromised as some package leaking has been observed. The affected product is packaged in a white aluminum tube with a paper carton. Global Pharma Healthcare has notified the brand owner and importer of this product, Delsam Pharma, of the recall and is encouraging wholesalers, retailers and consumers to discontinue use and discard the product safely and appropriately. To date, Global Pharma Healthcare has not received any reports of adverse events related to this over-the-counter product. Consumers can call Delsam Pharma at 1-866-826-1306 with any questions. They are advised to contact their health care provider if they have experienced any reactions. Adverse reactions relating to the recall should also be reported to the FDA’s MedWatch Adverse Event Reporting Program.

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From the Pharmaceutical Industry

Eli Lilly Implementing $35 Price Cap on Insulin Products

On March 1, 2023, Eli Lilly and Company announced its plan to reduce insulin costs by 70% and to cap patient out-of-pocket costs (OOP) for insulin products at $35 per month. Lilly is taking these actions to make their insulin products more accessible and affordable for the patients who need them. Individuals with diabetes who rely on insulin therapy and cannot afford it may skip doses or administer lower doses than required to ration what they can acquire. This puts them at risk of insufficient blood sugar control which can lead to a decline in kidney function, vision loss and amputation over time. Effective May 1, 2023, Lilly will offer its non-branded Insulin Lispro Injection for $25 per vial, making it the lowest list-priced mealtime insulin available. The prices of Lilly’s most prescribed insulins, Humalog® and Humulin®, will be cut by 70% later in 2023. Effective immediately, Lilly will automatically cap OOP costs at $35 at participating retail pharmacies for people with commercial insurance. Those without insurance can receive a savings card through Lilly’s Insulin Value Program to acquire their insulin for $35 per month.  Their actions follow the recent implementation of the Inflation Reduction Act which caps the price of insulin at $35 per month for Medicare beneficiaries.

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FDA Approvals

New FDA Approvals

Orphan Drug Approval: FilspariTM (sparsentan)

Oral tablet approved to lower protein levels in the urine of adults with a kidney disease known as primary immunoglobulin A nephropathy. [02/17/2023 – TRAVERE]

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New Generics

New Generics Entering the Marketplace

Zonalon® (doxepin) cream

Indication: Short-term treatment of moderate itching due to certain forms of skin inflammation, including eczema

Dosage Form/Strength: 5% topical cream, 45g tube 

Average Wholesale Price (AWP): Generic = $722 | Brand = $803