Clinical News: March 2024

March 27, 2024

Your monthly source for drug information highlights

Clinical News

Your monthly source for drug information highlights

Hot topics

CDC ISSUES HEALTH ADVISORY ON MEASLES

The Centers for Disease Control and Prevention (CDC) has issued an official health advisory regarding global and domestic increases in measles cases. Guidance is provided on measles prevention for all international travelers who are ≥ 6 months of age as well as all children ≥ 12 months of age who do not plan to travel internationally. The CDC has received reports of 58 confirmed U.S. cases and 7 outbreaks since the beginning of 2024 through mid-March. In contrast, in 2023, the total number of cases was 58 with 4 outbreaks reported. The vast majority of cases in 2024 have been associated with international travel with most cases occurring in children ≥ 12 months of age who had not received measles-mumps-rubella (MMR) vaccine. As a result, the CDC is recommending all U.S. residents who are traveling internationally, regardless of destination, to be current on their MMR vaccinations. Although the risk of widescale spread of measles is low due to overall high population immunity in most communities throughout the country, some communities are at higher risk due to low vaccine coverage.

Measles, also known as rubeola, is a highly contagious viral illness; one infected person can infect 9 out of 10 unvaccinated individuals through close contact. It is spread through direct contact with infectious droplets or airborne spread (breath, cough, sneeze). It can remain infectious in the air and on surfaces for up to 2 hours after an infected person leaves an area. Measles can cause serious health complications, such as pneumonia, encephalitis and death, particularly in unvaccinated individuals. Measles is preventable. Two doses of an MMR vaccine provide 97% efficacy against measles. For more information, visit CDC’s health advisory.

COVID-19 UPDATES

The U.S. Food and Drug Administration (FDA) issued an EUA for the OSOM® Flu SARS-CoV-2 Combo Test, the first OTC at-home antigen test to detect both influenza and COVID-19 viruses. The test is for detection and differentiation of influenza A and B and SARS-CoV-2 in patients with signs and symptoms of respiratory infection consistent with COVID-19 within the first 4 days of symptom onset when tested at least twice over 3 days with at least 48 hours between tests. It can be used in individuals ≥ 14 years of age via self-collection and in children ≥ 2 years old with an adult collecting the specimen. Collection occurs with a nasal swab. The FDA previously approved an at-home nucleic acid amplification test, Lucira®, that also allows for detection and differentiation of influenza A and B and SARS-CoV-2.

The CDC has released updated recommendations for protection against respiratory viruses (e.g., COVID-19, influenza, respiratory syncytial virus [RSV]) which include staying up to date with vaccinations, practicing good hygiene, and taking steps to have exposure to cleaner air. The new guidance recommends a shortened isolation period for individuals in the U.S. who test positive for COVID-19; patients can return to normal activities when symptoms are improving overall for ≥ 24 hours and fever (if present) is resolved for ≥ 24 hours without use of a fever-reducing medication. Additional precautions, such as physical distancing and use of masks, should be utilized during the return to normal activities for the next 5 days. An antigen test for COVID-19 infection can help determine contagiousness, as a positive result increases the potential for spreading the virus to others.

The CDC has endorsed the recommendation from the CDC Advisory Committee on Immunization Practices (ACIP) for adults ≥ 65 years of age to receive an additional updated 2023–2024 COVID-19 vaccine dose. This dose is recommended ≥ 2 months after the prior updated dose.

More trending topics

BEHAVIORAL HEALTH CORNER

Shortages of stimulants for ADHD are currently being reported by the FDA. This includes generic methylphenidate extended-release (ER) tablets as well as generic lisdexamfetamine dimesylate capsules and chewable tablets. Shortages of generic amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, dextroamphetamine sulfate immediate release (IR) tablets also continue to be reported from select manufacturers.

WEIGHT MANAGEMENT CORNER

Recently, the Congressional Budget Office (CBO) had issued a question and answer summary following a hearing on the oversight of the CBO. Questions have arisen regarding Medicare’s potential coverage of obesity medications. Specifically, CBO had stated that if the FDA approves glucagon-like peptide-1 (GLP-1) receptor agonists (GLP-1 RAs) for CV indications, it is expected Medicare will provide coverage for these indications in patients with obesity. Currently, the CBO is researching the number of individuals receiving treatment with anti-obesity medications and recognizes that ongoing use of these medications is generally required as discontinuation can result in regained weight and associated adverse health outcomes. The CBO’s evaluation of proposals to expand Medicare coverage of GLP-1 RAs takes into consideration the chronicity of use of these medications by the patient as well as the importance of continued medication coverage for those patients who transition from commercial insurance to Medicare. Semaglutide (Wegovy®) is FDA-approved for secondary prevention of cardiovascular disease (CVD) in adults with obesity or overweight.

CLINICAL CORNER

The FDA has approved the Dexcom Stelo Glucose Biosensor System as the first OTC continuous glucose monitor (CGM). The device is intended for use in adults who do not use insulin. This includes individuals with diabetes mellitus (DM) managed with oral medications as well as individuals without DM who want to monitor the impact of diet and exercise on their blood glucose levels. The system does not alert users to hypoglycemic episodes and therefore is not intended for those with problematic hypoglycemia. Dexcom Stelo Glucose Biosensor System includes a wearable sensor that pairs with an application (app) on a smartphone or other smart device and provides continuous data on the individual’s blood glucose measurements every 15 minutes. Sensors can be worn for up to 15 days. A clinical study demonstrated the system was comparable in performance to other integrated CGMs. The OTC CGM is expected to be available in summer 2024.

The FDA is reporting limited availability of dulaglutide (Trulicity®) 1.5 mg/0.5 mL and 4.5 mg/0.5 mL injection through April 2024 due to increased demand. The 0.75 mg/0.5 mL and 3 mg/0.5 mL strengths remain available. Trulicity is a GLP-1 RA indicated (1) as an adjunct to diet and exercise to improve glycemic control in patients ≥ 10 years of age with type 2 DM (T2DM) and (2) to reduce the risk of major adverse cardiovascular events (MACE) in adults with T2DM who have established CVD or multiple CV risk factors.

COVID-19: NOTABLE DEVELOPMENTS

The FDA has announced that only NDA-labeled nirmatrelvir tablets/ritonavir tablets (Paxlovid™) can now be dispensed for both NDA-approved and EUA-authorized uses. As EUA-labeled product is no longer authorized for emergency use, regardless of the labeled or extended expiration date, it should be disposed of or returned to manufacturer. This revision to the EUA marks the completion of the transition from EUA-labeled Paxlovid to FDA-approved Paxlovid.

The CDC published an MMWR on interim effectiveness of the updated 2023–2024 COVID-19 vaccines (monovalent XBB.1.5) against COVID-19-associated emergency department visits, urgent care encounters, and hospitalizations in immunocompetent adults. During the first 7 to 59 days following receipt of an updated dose, interim vaccine effectiveness (VE) against COVID-19-associated emergency department/urgent care encounters was 51% (95% confidence interval [CI], 47 to 54). During days 60 to 119 following an updated dose, interim VE was 39% (95% CI, 33 to 45). For protection against COVID-19-associated hospitalization, data from two CDC networks demonstrated VE estimates were 52% (95% CI, 47 to 57) and 43% (95% CI, 27 to 56); the median interval from an updated dose was 42 days and 47 days, respectively.

An upcoming Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting is planned for May 16, 2024. Recommendations on strain(s) for inclusion in the 2024–2025 formula for COVID-19 vaccines are expected.

INFLUENZA UPDATES

The CDC is reporting influenza-like illness (ILI) for the week ending March 16, 2024. Seasonal influenza activity remains elevated in the U.S. but is decreasing or stable in some regions; a slight increase is being reported in the Pacific Northwest. The most frequently reported viruses this week were influenza A (H3N2). As of March 4, 2024, the FDA is reporting available product from all manufacturers of antiviral influenza medications.

The CDC published an MMWR on interim estimates of the 2023–2024 seasonal influenza VE across the country. In pediatric individuals 6 months to 17 years of age, interim VE against outpatient visits was 59% to 67% and protection against hospitalization was 52% to 61%. In adults, interim VE against outpatient visits was 33% to 49% and protection against hospitalization was 41% to 44%.

The FDA’s VRBPAC convened on March 5, 2024 to determine the composition of the influenza vaccinations for the 2024–2025 influenza season. The committee recommended a trivalent vaccine composition for the upcoming influenza season. Trivalent vaccines will include two influenza A viruses (H1N1 and H3N2) and one influenza B virus. The change from quadrivalent influenza vaccines to trivalent influenza vaccines is based on removal of the influenza B/Yamagata lineage due to lack of confirmed detections of circulating B/Yamagata lineage viruses worldwide after March 2020.

BEHAVIORAL HEALTH CORNER

Shortages of stimulants for ADHD are currently being reported by the FDA. This includes generic methylphenidate extended-release (ER) tablets as well as generic lisdexamfetamine dimesylate capsules and chewable tablets. Shortages of generic amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, dextroamphetamine sulfate immediate release (IR) tablets also continue to be reported from select manufacturers.

WEIGHT MANAGEMENT CORNER

Recently, the Congressional Budget Office (CBO) had issued a question and answer summary following a hearing on the oversight of the CBO. Questions have arisen regarding Medicare’s potential coverage of obesity medications. Specifically, CBO had stated that if the FDA approves glucagon-like peptide-1 (GLP-1) receptor agonists (GLP-1 RAs) for CV indications, it is expected Medicare will provide coverage for these indications in patients with obesity. Currently, the CBO is researching the number of individuals receiving treatment with anti-obesity medications and recognizes that ongoing use of these medications is generally required as discontinuation can result in regained weight and associated adverse health outcomes. The CBO’s evaluation of proposals to expand Medicare coverage of GLP-1 RAs takes into consideration the chronicity of use of these medications by the patient as well as the importance of continued medication coverage for those patients who transition from commercial insurance to Medicare. Semaglutide (Wegovy®) is FDA-approved for secondary prevention of cardiovascular disease (CVD) in adults with obesity or overweight.

CLINICAL CORNER

The FDA has approved the Dexcom Stelo Glucose Biosensor System as the first OTC continuous glucose monitor (CGM). The device is intended for use in adults who do not use insulin. This includes individuals with diabetes mellitus (DM) managed with oral medications as well as individuals without DM who want to monitor the impact of diet and exercise on their blood glucose levels. The system does not alert users to hypoglycemic episodes and therefore is not intended for those with problematic hypoglycemia. Dexcom Stelo Glucose Biosensor System includes a wearable sensor that pairs with an application (app) on a smartphone or other smart device and provides continuous data on the individual’s blood glucose measurements every 15 minutes. Sensors can be worn for up to 15 days. A clinical study demonstrated the system was comparable in performance to other integrated CGMs. The OTC CGM is expected to be available in summer 2024.

The FDA is reporting limited availability of dulaglutide (Trulicity®) 1.5 mg/0.5 mL and 4.5 mg/0.5 mL injection through April 2024 due to increased demand. The 0.75 mg/0.5 mL and 3 mg/0.5 mL strengths remain available. Trulicity is a GLP-1 RA indicated (1) as an adjunct to diet and exercise to improve glycemic control in patients ≥ 10 years of age with type 2 DM (T2DM) and (2) to reduce the risk of major adverse cardiovascular events (MACE) in adults with T2DM who have established CVD or multiple CV risk factors.

COVID-19: NOTABLE DEVELOPMENTS

The FDA has announced that only NDA-labeled nirmatrelvir tablets/ritonavir tablets (Paxlovid™) can now be dispensed for both NDA-approved and EUA-authorized uses. As EUA-labeled product is no longer authorized for emergency use, regardless of the labeled or extended expiration date, it should be disposed of or returned to manufacturer. This revision to the EUA marks the completion of the transition from EUA-labeled Paxlovid to FDA-approved Paxlovid.

The CDC published an MMWR on interim effectiveness of the updated 2023–2024 COVID-19 vaccines (monovalent XBB.1.5) against COVID-19-associated emergency department visits, urgent care encounters, and hospitalizations in immunocompetent adults. During the first 7 to 59 days following receipt of an updated dose, interim vaccine effectiveness (VE) against COVID-19-associated emergency department/urgent care encounters was 51% (95% confidence interval [CI], 47 to 54). During days 60 to 119 following an updated dose, interim VE was 39% (95% CI, 33 to 45). For protection against COVID-19-associated hospitalization, data from two CDC networks demonstrated VE estimates were 52% (95% CI, 47 to 57) and 43% (95% CI, 27 to 56); the median interval from an updated dose was 42 days and 47 days, respectively.

An upcoming Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting is planned for May 16, 2024. Recommendations on strain(s) for inclusion in the 2024–2025 formula for COVID-19 vaccines are expected.

INFLUENZA UPDATES

The CDC is reporting influenza-like illness (ILI) for the week ending March 16, 2024. Seasonal influenza activity remains elevated in the U.S. but is decreasing or stable in some regions; a slight increase is being reported in the Pacific Northwest. The most frequently reported viruses this week were influenza A (H3N2). As of March 4, 2024, the FDA is reporting available product from all manufacturers of antiviral influenza medications.

The CDC published an MMWR on interim estimates of the 2023–2024 seasonal influenza VE across the country. In pediatric individuals 6 months to 17 years of age, interim VE against outpatient visits was 59% to 67% and protection against hospitalization was 52% to 61%. In adults, interim VE against outpatient visits was 33% to 49% and protection against hospitalization was 41% to 44%.

The FDA’s VRBPAC convened on March 5, 2024 to determine the composition of the influenza vaccinations for the 2024–2025 influenza season. The committee recommended a trivalent vaccine composition for the upcoming influenza season. Trivalent vaccines will include two influenza A viruses (H1N1 and H3N2) and one influenza B virus. The change from quadrivalent influenza vaccines to trivalent influenza vaccines is based on removal of the influenza B/Yamagata lineage due to lack of confirmed detections of circulating B/Yamagata lineage viruses worldwide after March 2020.

Drug information happenings & highlights

DRUG INFORMATION HIGHLIGHTS

  • Perrigo has announced that the progestin-only, daily oral contraceptive norgestrel (Opill®) is now available for preorder from select retailers. Approved for OTC use in July 2023, Opill is anticipated to be available in stores and online in March 2024 and is the first and only oral contraceptive available OTC in the U.S.
  • The CDC has published an MMWR reporting on early data regarding the effectiveness of the long-acting monoclonal antibody nirsevimab-alip (Beyfortus®). Effectiveness of nirsevimab was found to be 90% against RSV-associated hospitalization in infants during their first RSV season.
  • Amylyx has announced potential voluntary withdrawal of sodium phenylbutyrate and taurursodiol oral suspension (Relyvrio®) indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults. The PHOENIX trial did not meet the primary endpoint assessing the change from baseline in the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) total score at week 48. As a result, findings from this study will be discussed with regulatory authorities and the ALS community in order to make an informed decision regarding commercial availability of the medication.
  • Par has issued a voluntary recall of one lot of the injectable pulmonary arterial hypertension medication treprostinil (20 mg/20 mL). The recall is due to potential silicone particulates in the product solution.
  • Brassica has voluntarily recalled certain lots certain lots of specific OTC eye ointment products due to lack of sterility assurance at the facility that was observed during FDA inspection. Recalled products include Equate™ Lubricant Eye Ointment, Equate Stye™ Lubricant Eye Ointment, CVS Health® Lubricant Eye Ointment, and Lubricant PM Ointment. For patients who use these recalled products, there is a potential risk of eye infections or similar problems, as ophthalmic products are intended to be sterile.
  • Eli Lilly is reporting discontinuation of insulin (human) (Humulin® R) U-100 3 mL vials. Humulin R U-100 will continue to be available in 10 mL vials.
  • Alvogen has announced that it will discontinue manufacture of generic melphalan 2 mg tablets due to low sales volume; supply is currently available with April 2024 expiration dates. Brand product, Alkeran®, from Apopharma remains on the market.
  • Bayer has announced that it will discontinue manufacture of praziquantel (Biltricide®) 600 mg tablets; generic product from Par remains available. Biltricide is an anthelmintic indicated for specific parasitic infections.

DRUG INFORMATION HAPPENINGS

  • The American Academy of Otolaryngology – Head and Neck Surgery Foundation has issued a clinical practice guideline on the management of inhalant allergies with allergen immunotherapy (AIT). AIT involves therapeutic exposure to allergens based on clinical evaluation/allergy testing in order to reduce allergic symptoms and induce tolerance.
  • The CMS has released final guidance on the Medicare Prescription Payment Plan, which will begin in 2025. Enrollees of Medicare Part D plans (standalone prescription drug plans and Medicare Advantage plans with drug coverage) will have the option of paying out-of-pocket prescription drug costs as capped monthly payments rather than all at once at the pharmacy.
  • The American Gastroenterological Association (AGA) published a clinical practice guideline on fecal microbiota-based therapies for select gastrointestinal diseases, such as recurrent Clostridioides  difficile (C. difficile) infection. These therapies include conventional fecal microbiota transplant and FDA-approved therapies (fecal microbiota, live-jslm [Rebyota™] and fecal microbiota spores live-brpk [Vowst™]).
  • The Endocrine Society has published a position statement on prioritization of patient experiences during the management of diabetes and its complications. The position statement focuses on the importance of patient-provider communication, addressing psychosocial conditions, education and support for self-management, helping patients navigate therapeutic options, overcoming therapeutic inertia, decreasing the risk of CVD and microvascular complications, preventing and managing hypoglycemia, as well as use of telehealth and technology in the management process.
  • The Institute for Clinical and Economic Review (ICER) published a final evidence report on the investigational product xanomeline/trospium (KarXT) for the treatment of schizophrenia.
  • ICER issued a final evidence report on use of iptacopan (Fabhalta®) and the investigational product danicopan for the treatment of paroxysmal nocturnal hemoglobinuria.
Glossary of terms

ADHD = attention deficit hyperactivity disorder

EUA = Emergency Use Authorization

MMWR = Morbidity and Mortality Weekly Report

NDA = New Drug Application

OTC = over the counter

SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2

Editorial team

EDITOR-IN-CHIEF: Maryam Tabatabai, PharmD

EXECUTIVE EDITOR: Anna Schreck Bird, PharmD

DEPUTY EDITORS: Erik Hamel, PharmD; Olivia Pane, PharmD, CDCES

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