Several drugs have been approved by the Food and Drug Administration (FDA) in June 2021 that are relevant to common conditions managed by nurse practitioners (NPs) and PAs. These approvals are inclusive of new treatments for smallpox, weight management, candidiasis, and Alzheimer disease.
Aduhelm for Alzheimer Disease
Aduhelm™ (aducanumab-avwa) is a monthly intravenous infusion approved for the treatment of patients diagnosed with Alzheimer disease.1 The FDA granted accelerated approval for Aduhelm, the first novel treatment for Alzheimer disease since 2003.
The approval is not without controversy. In November 2020, the agency’s Peripheral and Central Nervous System drug advisor committee voted against recommending the drug for approval. After the drug’s approval, 2 members of the committee, David S. Knopman, MD, and Joel S. Perlmutter, MD, resigned.2
The FDA released a press release defending their decision to approve the new agent, citing the novel mechanism of action that is directed at amyloid beta plaques in the brain of patients with Alzheimer disease. “The clinical trials for Aduhelm were the first to show that a reduction in these plaques—a hallmark finding in the brain of patients with Alzheimer’s—is expected to lead to a reduction in the clinical decline of this devastating form of dementia,” noted the FDA.3
The prescribing information of Aduhlm was updated in early July to reflect a more narrow patient population than the originally approved indication. The new label reads: “Aduhelm is indicated for the treatment of Alzheimer’s disease. Treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied…. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).”1
Approval was based on the phase 3 EMERGE study and results showed a significant decrease of 22% in Clinical Dementia Rating-Sum of Boxes (CDR-SB) scores at week 78 when Aduhelm was used in high doses. Most adverse reactions included amyloid-related imaging abnormalities (ARIA)-edema, ARIA-hemosiderin deposition (ARIA-H) microhemorrhage, ARIA-H superficial siderosis, headache, and fall.
Aduhelm is supplied in single-dose vials in 170 mg/1.7 mL and 300 mg/3 mL strengths and titration is required before treatment.
Tembexa for Smallpox
For adults, pediatric patients, and neonates with human smallpox disease, Tembexa® (brincidofovir), an orthopoxvirus nucleotide analogue DNA polymerase inhibitor, has been approved for treatment under the FDA Animal Rule.4 This allows findings from animal efficacy studies to determine the approval of a drug when ethical studies in humans are unable to be conducted.
This treatment is available in both tablet and oral suspension forms and is safe for adults and pediatric patients. The safety of Tembexa was based on 2 phase 3 trials, which investigated the drug for a non-smallpox indication, mainly in patients who underwent hematopoietic stem cell transplants. Adverse reactions of Tembexa include diarrhea, nausea, vomiting, and abdominal pain.
Wegovy for Weight Management
Wegovy™ (semaglutide) is a once-weekly injection that was approved by the FDA as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adults who are obese (BMI ≥30) or overweight (BMI ≥27) and diagnosed with at least 1 weight-related comorbid condition.5
Wegovy targets specific areas of the brain that regulate food intake and appetite. The approval was based on several double-blind, placebo-controlled studies and is supplied as prefilled, single-dose pens that contain doses of 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, or 2.4 mg. The once-weekly treatment can be administered by the patient once they have been adequately trained in the self-injection method.
Brexafemme for Candidiasis
Brexafemme® (ibrexafungerp tablets) is an oral antifungal agent approved for treatment of vulvovaginal candidiasis in women. It has shown broad spectrum antifungal activity against multidrug-resistant pathogens and is supplied as 150 mg tablets in 4-count blister packs.
Adverse reactions may include diarrhea, nausea, abdominal pain, dizziness, and vomiting. Based on animal studies, Brexafemme should not be used during pregnancy as it may cause harm to the fetus.6
1. Aduhelm. Prescribing information. Biogen; 2021. Accessed July 15, 2021. https://www.biogencdn.com/us/aduhelm-pi.pdf
2. House committees to investigate new Alzheimer disease drug approval. Neurology Advisor. July 9, 2021. Accessed July 15, 2021. https://www.neurologyadvisor.com/topics/alzheimers-disease-and-dementia/house-committees-to-investigate-new-alzheimer-disease-drug-approval/
3. US Food and Drug Administration. FDA’s decision to approve new treatment for Alzheimer’s disease. June 7, 2021. Accessed July 15, 2021. https://www.fda.gov/drugs/news-events-human-drugs/fdas-decision-approve-new-treatment-alzheimers-disease
4. Tembexa. Prescribing information. Chimerix; 2021. Accessed July 14, 2021. https://www.chimerix.com/wp-content/uploads/2021/06/TEMBEXA-USPI-and-PPI-04June2021.pdf
5. Wegovy. Prescribing information. Novo Nordisk; 2021. Accessed July 14, 2021. https://www.novo-pi.com/wegovy.pdf
6. Brexafemme. Prescribing information. Syncnexis; 2021. Accessed July 14, 2021. https://d1io3yog0oux5.cloudfront.net/scynexis/files/pages/scynexis/db/pis/Digital+Ibrexafungerp+Prescribing+Information+%28PI%29.pdf