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Pulse Newsletter

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

Volume 5 | Issue 2
February 1, 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

FDA Grants Accelerated Approval for Alzheimer’s Disease Treatment

On January 6, 2023, the U.S. Food & Drug Administration (FDA) granted accelerated approval for Leqembi (lecanemab-irmb), for the treatment of Alzheimer’s disease in patients with mild cognitive impairment or mild dementia. Alzheimer’s disease is the most common cause of dementia in patients experiencing memory loss or cognitive changes, affecting about 6.5 million Americans. It is classified as a progressive neurodegenerative disease, with symptoms worsening over time for patients. Difficulty recalling newly learned information is often the most common early symptom of Alzheimer’s disease. As the disease progresses, patients can develop severe symptoms like extreme memory loss and behavioral changes. Symptoms are caused by the destruction of brain cells due to the development of beta-amyloid plaque deposits and tangles within the brain.

Leqembi is the second drug in its class approved for the treatment of Alzheimer’s disease, following the approval of Aduhelm™ (aducanumab) in 2021. Rather than treating symptoms of the disease like established treatments, these drugs target the biological cause of the disease. The efficacy of Leqembi was determined by observing the reduction of amyloid beta plaques in areas of the brain most likely associated with clinical symptoms. Reduction in these plaques is expected to be predictive of clinical benefit in slowing progression of the disease. The drug was evaluated in a study of 856 patients with mild cognitive impairment or mild dementia with a confirmed presence of amyloid beta plaques. Patients received doses of Leqembi every two weeks based on their body weight. Compared to the placebo group, the patients receiving Leqembi had a significant reduction in beta amyloid plaques after 79 weeks of treatment. These results led to accelerated approval, and the FDA will soon review the results of the Phase 3 randomized, controlled confirmatory clinical trial. The FDA granted Leqembi Fast Track, Priority Review, and Breakthrough Therapy designations.

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Drug Safety

Quinapril Recall Due to Nitrosamine Impurity

On December 21, 2022, Lupin Pharmaceuticals Inc. announced a voluntary recall of four lots of quinapril tablets due to nitrosamine impurity. Quinapril is classified as an ACE-inhibitor and is commonly used to lower blood pressure and decrease risk of cardiovascular events in patients with hypertension. The presence of nitrosamine impurities could increase cancer risk for patients exposed to them for a long period of time. The four recalled lots were 90-count vials of quinapril 20mg or 40mg tablets distributed between March 15, 2021 and September 1, 2022. Lupin Pharmaceuticals Inc. has notified wholesalers, distributors and pharmacies to stop distribution of these recalled lots and is arranging for them to be returned. Patients are encouraged to continue their quinapril therapy and contact their health care providers regarding alternative treatments. Adverse reactions relating to the recall should be reported to the FDA’s MedWatch Adverse Event Reporting Program. To date, Lupin Pharmaceuticals Inc. has not received reports of any adverse events relating to this recall.

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From the Pharmaceutical Industry

Diabetes Rates Increasing in Young People

On December 29, 2022, the Centers for Disease Control and Prevention (CDC) shared a press release warning of the projected increase in diabetes diagnoses in young patients under 20 years old. Based on a study published by Diabetes Care, current trends could lead to as much as a 65% increase of young people with type 1 diabetes and 700% increase in young people with type 2 diabetes. Type 1 diabetes is an auto-immune condition that often presents early in life and results in the inability to produce insulin. Type 2 diabetes develops over time and results from a patient’s lifestyle, causing the body to have a lower response to insulin. In 2017, 213,000 young people in the United States were diagnosed with diabetes, with an estimated 526,000 being diagnosed with diabetes by 2060. Patients with diabetes are at an increased risk of medical complications, heart disease, stroke and premature death.

Increasing prevalence of childhood obesity has a large effect on the increase of type 2 diabetes in young patients. On January 9, 2023, the American Academy of Pediatrics developed guidelines regarding evaluation and treatment of obesity in children and adolescents. To date, over 14.4 million children and adolescents in the United States are obese, increasing the risks for both short-term and long-term health complications. Obesity and its treatment have always been sensitive topics and must be approached with empathy and understanding. These guidelines encourage a comprehensive approach, considering physiologic, genetic, environmental and socioeconomic factors that may increase a patient’s risk. Using evidence-based research, the American Academy of Pediatrics provides recommendations for assisting patients with weight loss using a variety of options including behavioral therapy, physical activity, nutrition, pharmacotherapy and metabolic and bariatric surgery. It has shown that obesity treatment is safe and effective in adolescent patients and is strongly encouraged to decrease risks of further health problems such as type 2 diabetes.

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FDA Approvals

New FDA Approvals

Orphan Drug Approval: Sunlenca® (lenacapavir)

Oral tablet and subcutaneous injection approved for the treatment of HIV-1 infection in adult patients currently failing their antiretroviral therapy due to resistance, intolerance or safety considerations. [12/22/2022 – GILEAD SCIENCES]

New Drug Combination Approval:  Airsupra™ (albuterol and budesonide)

Inhaler approved for as-needed treatment or prevention of asthma attacks in adults. [01/10/2023 –ASTRAZENECA] 

New Drug ApprovalOrserdu™ (elacestrant)

Tablets approved for the treatment of advanced or metastatic breast cancer in postmenopausal women or adult men with disease progression following at least one trial of hormone therapy who’s cancer has been determined to be a certain type known as ER-positive, HER2-negative, ESR1-mutated. [01/27/2023 – Priority Review – MENARINI] 

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New Generics

New Generics Entering the Marketplace

Xyrem® (sodium oxybate solution)
Indication: Excessive daytime sleepiness
Dosage Form/Strength: 180mL 0.5 g/mL oral solution
Average Wholesale Price (AWP): Generic = $961 | Brand = $963

Latuda® (lurasidone)
Indication: Schizophrenia or bipolar depression
Dosage Form/Strength: 20mg, 40mg, 60mg, 80mg, 120mg oral tablets
Average Wholesale Price (AWP): Generic = $1,531 | Brand = $1,703