Pulse Newsletter
Your source for the latest industry trends and drug information news.
Volume 3 | Issue 16
August 15, 2021
Contributors:
Chief Author: Dana Ranallo, PharmD
Contributing Author: James Pufpaff, PharmD/MBA Candidate
Medical Icon Set Sheet
Clinical Pharmacy Update
FDA Approves Once-Weekly Exenatide for Children with Type 2 Diabetes
On July 23, 2021, the U.S. Food and Drug Administration (FDA) approved Bydureon BCise® (exenatide extended-release) to improve blood sugar control when added to diet and exercise for children aged 10 to 17 years with type 2 diabetes (T2D). Bydureon BCise® is a type of medication known as a GLP-1 receptor agonist (GLP-1 RA), which work by magnifying the release of insulin that occurs as a response to an increase in blood sugar levels. The first GLP-1 RA was approved for the treatment of T2D in 2009, and since then, the class of medication has been recognized for their additional cardiovascular benefit and potential to promote weight loss. Bydureon BCise® was originally approved for the treatment of T2D in adult patients in 2017. T2D is a chronic disease that affects the way the body processes blood sugar and has increased in prevalence within children and adolescent population since the mid-1990s. Without lifestyle modifications and treatment, T2D may lead to elevated blood sugar levels and subsequent complications such as cardiovascular disease, nerve damage, and decline in kidney function. The efficacy and safety of Bydureon BCise® was evaluated in a 24-week study, including 82 pediatric patients aged 10 to 17 years with T2D who were randomly assigned to treatment with either exenatide extended-release or placebo. The study evaluated changes in hemoglobin A1c (HbA1c) which correlates with average blood sugar levels over the prior three months, with higher values being associated with uncontrolled T2D and an increased risk for complications. Results from the study showed that patients who were treated with exenatide extended release experienced an average decrease in their HbA1c of 0.25%, while the placebo group experienced an average increase in HbA1c of 0.45%. The study also demonstrated that the adverse events observed were comparable to those observed in adult patients. With this approval, Bydureon BCise® is the first once-weekly GLP-1 RA treatment option for children with T2D in the United States.
Drug Safety
KVK Recalls Atovaquone Oral Suspension Due to Temperature Abuse
On August 06, 2021, KVK Tech Inc. initiated a voluntary recall of two lots of Atovaquone Oral Suspension 750mg/5mL. Atovaquone is used to prevent and treat Pneumocystis jiroveci pneumonia, which is a type of pneumonia caused by a fungal infection that is most commonly seen in teenagers and adults with weakened immune systems, including human immunodeficiency virus (HIV) patients. The recall was initiated following customer complaints of “unusual grittiness” of the product. KVK determined that the most probable cause was prolonged exposure to extremely cold temperatures during shipment, which may result in changes to the consistency, taste and efficacy of the product. Treatment of patients with a severely weakened immune system using less effective Atovaquone may result in inadequate treatment of infection. While KVK had not received any complaints or reports of any adverse events at the time of the recall, the company has requested that patients who have medicine affected by this recall stop using the product and has provided instructions for return and reimbursement. Adverse reactions or quality problems related to the recall should be made to the FDA’s MedWatch Adverse Event Reporting Program.
From the Pharmaceutical Industry
Drug Makers Targeting Seasonal Flu with mRNA Technology
Pharmaceutical companies like Moderna, Sanofi, GlaxoSmithKline and Pfizer are working on developing mRNA-based vaccines for the influenza virus. mRNA vaccines have been making headlines as they received FDA Emergency Use Authorization to help combat the ongoing COVID-19 pandemic. They differ from traditional vaccines as they do not contain an inactivated or weakened virus component. Instead, they work by providing the genetic code for a protein which can be used by the human body to mount an immune response against potential future infections. A significant downside of traditional influenza vaccines is the expensive and time-consuming development process. Additionally, the flu virus often mutates and new strains develop by the time the vaccine becomes available, leading to lower efficacy rates, typically between 40-60%. Conversely mRNA vaccines have demonstrated efficacies as high as 95% against COVID-19 and can typically be developed shortly after knowing the genetic sequence of the virus. This quicker development process may allow for better targeting against the most prevalent strains of the virus closer to the start of the flu season. It is expected there may even be a place for rapidly developed “booster” shots if there are strains missed by the earlier vaccines. While mRNA vaccines may be cheaper to develop and can be brought to market much faster than traditional vaccines, one downside is they do often carry strict storage requirements. As this technology continues to develop, the implementation of mRNA-based vaccines will provide public health officials another tool in the fight against yearly flu outbreaks.
FDA Approvals
New FDA Drug Approvals
Novel Drug Approval: Rezurock® (belumosudil mesylate)
Oral tablets approved for the treatment of chronic graft-versus-host disease (GVHD) for patients aged 12 years and older who have tried and failed at least two other systemic therapies. [07/16/21 – Fast Track; Priority Review; Orphan Drug – KADMON PHARMS LLC]
Novel Drug Approval: Bylvay® (odevixibat)
Oral capsules and pellets approved for the treatment of pruritus (itching) in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC), a rare inherited liver condition with severe itching as a hallmark symptom. [07/20/21 – Fast Track; Priority Review; Orphan Drug – ALBIREO PHARMA INC]
New Generics
New Generic Medications Entering the Marketplace*
Duexis® (ibuprofen/famotidine)
Indication: To relieve signs and symptoms of osteoarthritis and rheumatoid arthritis (RA), while simultaneously reducing the risk of developing upper GI ulcers, a potential adverse effect associated with the NSAID componet (ibuprofen) of this combination medication.
Dosage Form/Strength: 800-26.6 MG Oral tablets
Average Wholesale Price (AWP): Generic = $998 | Brand = $2,979