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Pulse Newsletter

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

Volume 3 | Issue 6
March 15, 2021

Chief Author: Dana Ranallo, PharmD
Contributing Author: James Pufpaff, PharmD/MBA Candidate

Clinical Update

FDA Authorizes Third COVID-19 Vaccine

On February 27, 2021, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for Johnson & Johnson’s COVID-19 vaccine for use in individuals 18 years and older. The vaccine is the third to be authorized for use in the U.S., but the first that requires only a single dose. While both the Pfizer and Moderna vaccine utilize genetic technology, specifically mRNA technology, J&J’s vaccine uses an adenovirus vector, a weakened version of the virus associated with the common cold, to deliver a piece of COVID-19 DNA that cannot cause the disease but does cause cells in the body to produce a “spike” protein. This “spike” protein, or antigen, is detected by immune cells that trigger an immune response and formation of antibodies. Circulating antibodies are then available to provide defense against the COVID-19 virus if the individual were to be infected. In order to receive an EUA from the FDA, the vaccine was held to the same safety, efficacy and quality standards as its predecessors from Pfizer/BioNTech and Moderna. FDA analysis of an ongoing study with close to 40,000 participants showed that the vaccine was approximately 67% effective in preventing moderate to severe COVID-19 occurring at 14 days after vaccination and 85% effective in preventing severe COVID-19 at 28 days after vaccination. It is still to be determined the duration of protection provided by the vaccine, as well as whether it prevents asymptomatic individuals from transmitting the disease. With three different COVID-19 vaccines on the market now, health experts advise that individuals not wait for a specific vaccine but instead get whichever vaccine becomes available to them first.

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Safety First

Adverse Event Considerations When Using Adalimumab for Rare Skin Condition

On March 5, 2021, Dermatology Advisor published the results of a study measuring the impact of adalimumab, also known as Humira®, on quality of life and management of physical symptoms when used for hidradenitis suppurativa (HS). HS is a rare skin condition that progresses from obstructed hair follicles to sensitive, red nodules and infected areas known as abscesses. Recurrent formation and healing of these skin lesions often causes scarring, which can be disabling in severe cases. A recent study evaluated 101 adult patients who had failed traditional treatment options, such as topical steroids, and had been using adalimumab for at least six months. The study assessed both severity of physical symptoms and overall quality of life. Of the 78 patients with sufficient reportable data, 62 of them (79%) experienced improvement in physical symptoms, including reduction in discharge from abscesses, pain, nodules and even complete remission. A similar trend was seen in quality-of-life measures, with a significant improvement reported by nearly half the patient population enrolled. While adalimumab did prove to be efficacious in the physical management of HS, 32 of the 101 patients (31.7%) reported adverse effects. Three patients who had prior history of mental health disorder experienced psychological side effects including depression, obsessive compulsive disorder (OCD), increasing symptoms of anorexia and worsening of suicidal ideation. Additionally, 28 of the patients (27.7%) discontinued treatment, with 20 of the total 28 attributing the discontinuation to adverse events. Adalimumab presents an effective treatment option for HS, but patients should be monitored regularly for mental and physical side effects.

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From the Industry

Lilly’s Dual Acting Diabetes Medication Reaches Primary Endpoint

Eli Lilly and Company is looking to shake up the GLP-1a diabetes market with its novel, dual acting injectable agent, tirzepatide. Tirzepatide, a once-weekly injection, combines the actions of a glucagon-like-peptide-1 (GLP-1) receptor agonist with the actions of a hormone known as glucose-dependent insulinotropic polypeptide (GIP). Similar to GLP-1, GIP is a hormone released from the intestines in response to the intake of food and works to both stimulate insulin secretion and promote mealtime satiety. Elevating levels of GIP and GLP-1 simultaneously has been shown to provide a synergistic effect on blood glucose control and bodyweight management. In December 2020, data from a phase 3 trial enrolling adults with type 2 diabetes, SURPASS-1, showed that tirzepatide monotherapy was superior to placebo in reducing both A1C and bodyweight, with the highest dose resulting in a 2.07% reduction in A1C and greater than a 20-pound weight loss over the 40-week study. Furthermore, more than half of participants achieved an A1C less than 5.7%, comparable to levels seen in patients without diabetes. New data from two additional phase 3 trials, SURPASS-3 and SURPASS-5, showed that tirzepatide led to superior A1C and bodyweight reductions when compared to insulin degludec, a long acting insulin known as Tresiba®, and when compared to placebo in adults with type 2 diabetes already taking another long acting insulin, commonly known as Lantus®. Safety results associated with the trials indicated increased incidence of gastrointestinal effects, such as nausea and diarrhea, compared to placebo and lower risk of hypoglycemic events when compared to long-acting insulins. Lilly is hoping to use the safety and efficacy results found in these clinical trials to support an FDA approval of tirzepatide.

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FDA Approvals

Recent FDA Approvals

Novel Drug Approval: Cosela™ (trilaciclib)
Intravenous injection approved for reducing the occurrence of chemotherapy-induced decreases in bone marrow activity (myelosuppression) in adults with extensive-stage small cell lung cancer [2/12/21 – Priority Review – G1 THERAP]

Novel Drug Approval: Amondys 45™ (casimersen)
Intravenous infusion approved for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a specific confirmed genetic mutation [2/25/21 – Orphan DrugPriority Review – SAREPTA THERAPS INC]

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New Generics

New Generics Entering the Marketplace

Northera® (droxidopa)
Indication: Treatment of orthostatic dizziness, lightheadedness, or the “feeling that you are about to blackout” in adults with symptomatic neurogenic orthostatic hypotension (nOH).
Dosage Form/Strength: 100, 200, 300 MG Capsules
Average Wholesale Price (AWP): Generic = $103-$625 | Brand = $123-$736