Pulse Newsletter
Your source for the latest industry trends and drug information news.
Volume 3 | Issue 13
July 1, 2021
Contributors:
Chief Author: Dana Ranallo, PharmD
Contributing Author: James Pufpaff, PharmD/MBA Candidate
Clinical Pharmacy Update
FDA Grants Accelerated Approval for New Drug to Treat Alzheimer’s Disease
On June 7, 2021, the U.S. Food and Drug Administration (FDA) approved Aduhelm™ (aducanumab-avwa) for the treatment of Alzheimer’s disease, an irreversible, progressive disease that typically affects people 65 and older. At the onset of disease, individuals may experience mild memory loss, but in late stages it can cause severe memory loss and a multitude of other dementia-related symptoms, including cognitive and behavioral issues. Alzheimer’s is the sixth-leading cause of death in the United States with the average person living 4-8 years after diagnosis. One of the main characteristics of Alzheimer’s is the buildup of deposits of protein in the brain, known as amyloid beta plaque, which lead to damage and death of nerve cells resulting in a decline in neurological function. This leads to memory failure, personality changes and problems carrying out daily activities of living. While there is no cure for Alzheimer’s, Aduhelm™, which is infused intravenously, is the first FDA-approved medication that works to slow the progression of the disease due to its unique mechanism of action, which works by binding to the protein deposits, and reduces the amount of plaque seen through imaging. This in contrast to other medications on the market which do not target plaque and only work to manage the symptoms. Aduhelm™ was granted the FDA’s Fast Track designation, and approved via the accelerated approval pathway, after results from three separate double-blind, randomized, placebo-controlled studies showed that individuals receiving Aduhelm™ had significant reduction of plaque in the brain, while individuals who received placebo experienced no reduction in plaque. Aduhelm™ carries a warning for amyloid-related imaging abnormalities (ARIA) that can occur and result in temporary swelling in areas of the brain that are usually symptomless but may result in more serious side effects such as headache, confusion, vision changes, and dizziness. The most common side effects of the drug include ARIA, headache, fall, diarrhea and confusion/delirium/altered mental status/disorientation. While the data from the clinical trials appears promising, there is concern regarding the high cost of the medication and continued clinical benefit in this patient population. As a result, the FDA is requiring the manufacturer, Biogen, to conduct an additional clinical trial to further verify the clinical benefit of Aduhelm™ and will await results.
Drug Safety
Nationwide Recall of Metformin HCl ER Tablets
On June 11, 2021, the FDA released a drug safety communication regarding a voluntary nationwide recall of two lots of metformin hydrochloride extended-release 750 mg tablets produced by Cadila Healthcare Limited and distributed by Viona Pharmaceuticals Inc. The recall was made after it was found that the affected lots contained levels of Nitrosodimethylamine (NMDA) impurities above acceptable daily limits. NMDA is a known environmental contaminant that is classified as a probable cancer-causing substance. Metformin is an antidiabetic agent that helps patients with diabetes control their blood sugar levels. Since the potential consequences of discontinuing metformin may be greater than potential adverse effects of the contaminant, patients are advised to not make any changes to the way they are taking their medication without first consulting their physician for guidance. Questions regarding the recall can be made to Viona’s recall processor, Eversana Life Science Services Viona Pharmaceuticals Inc. is notifying customers and arranging for return of all recalled products. As of June 11, 2021, Viona Pharmaceuticals Inc. has not received any reports of serious adverse events to this recall. Adverse reactions or concerns related to the recall should be made to Viona Pharmaceuticals Inc., as well as to the FDA’s MedWatch Adverse Event Reporting Program. Patients and health care providers who wish to stay informed on FDA updates and press announcements related to metformin recalls related to NMDA can do so by visiting the agency’s website.
From the Pharmaceutical Industry
FDA Approves Pfizer’s New Pneumococcal Vaccine
On June 8, 2021, Pfizer announced the FDA’s accelerated approval of Prevnar 20™ (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of pneumococcal disease and pneumonia in adults 18 and older. The Prevnar 20™ vaccine includes coverage for 20 of the over 100 different variations of the bacteria responsible for causing pneumococcal disease and pneumonia, Streptococcus pneumoniae. This includes the 13 variations already included in the Prevnar 13® vaccine, as well as 7 others that are responsible for 40% of cases and deaths due to pneumococcal disease in the U.S., according to Pfizer. The accelerated approval comes after evidence from three Phase 3 trials established the safety and efficacy of the new vaccine when compared to Prevnar 13®. Over 6,000 adults 18 and older, including those over 65, those who had received prior pneumococcal vaccination, and those who had not received a prior pneumococcal vaccination were included in the trials. Results showed that safety outcomes and immune responses after Prevnar 20™ administration were comparable to those in a control group receiving the Prevnar 13®. The U.S. Centers for Disease Control and Preventions advisory committee is expected to meet later this year to discuss updating recommendations on the safe and appropriate use of pneumococcal vaccines in adults.
FDA Approvals
New FDA Drug Approvals
Novel Drug Approval: Brexafemme® (ibrexafungerp)
Oral tablet approved to treat vulvovaginal candidiasis (VVC) in adult and pediatric females who have begun menstruating [6/1/21 – Priority Review – SCYNEXIS]
New Generics
New Generic Medications Entering the Marketplace
Kaletra® (lopinavir/ritonavir)
Indication: Human Immunodeficiency Virus (HIV) Dosage Form/Strength: 100-25MG, and 200-50MG Oral tablet Average Wholesale Price (AWP): Generic = $276-$1,106 | Brand = $307-$1,229