Your source for the latest industry trends and drug information news.
Volume 6 | Issue 4
February 15, 2024
Contributors:
Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Gabrielle Graca, PharmD/MBA Candidate and Salome Mawi, PharmD/MBA Candidate
On January 25, 2024, the U.S. Food and Drug Administration (FDA) approved Dupixent® (dupilumab) to be used in the treatment of eosinophilic esophagitis (EoE) for pediatric patients ages 1 to 11 years and weighing at least 33 lbs. The drug was first approved for this indication in May 2022 for patients 12 years and older and weighing at least 88 lbs. This expanded approval for younger pediatric patients was granted under Priority Review. Approximately 21,000 children in the United States ages 12 years and younger carry an EoE diagnosis. This chronic, progressive disease can result in damage to the esophagus and its functioning. Symptoms of EoE include difficulty swallowing, impaired ability to eat, vomiting, abdominal discomfort and heartburn. The pain and discomfort often lead to refusal to eat and difficulty gaining weight, thereby slowing growth and development. Dupixent® is a monoclonal antibody that targets the two main inflammatory pathways associated with the underlying cause of EoE. Prior to this approval, treatment of younger patients with EoE was limited to the off-label use of medications for symptom management rather than therapies that addressed the root cause. In clinical trials, 66% of participants in the younger age range achieved disease remission after 16 weeks of treatment with Dupixent®, defined as a reduction in the number of eosinophils in the esophageal lining. They also experienced a greater reduction in the proportion of days they experienced symptoms of EoE, compared to those given a placebo. The main side effects of Dupixent® include joint pain, injection site reactions and increased risk of infection. Dupixent® was proven to be effective and well-tolerated in the management of EoE in children under the age of 12 and offers the first FDA-approved treatment option for this population.
On January 24, 2024, the FDA announced Haleon’s voluntary recall of eight lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult due to microbial contamination. These products are used for the temporary relief of symptoms occurring with cold, flu, hay fever or other allergies. The reported microbial contamination could increase the risk of infection requiring medical intervention. Patients who are immunocompromised are at the greatest risk of developing a severe or life-threatening fungal infection. Patients should contact their health care provider if they experience any effects that may be associated with this recall. To date, no adverse events have been reported in relation to the recalled products. Adverse reactions may be reported to the FDA’s MedWatch Adverse Event Reporting program.
On January 31, 2024, executives at Novo Nordisk announced that Novo has doubled the supply of Wegovy® (semaglutide) starter doses to meet the growing demand for the drug. Wegovy® entered the U.S. market in 2021 with the FDA-approved indication of chronic weight management as an adjunct to diet and exercise. Novo was faced with supply issues for Wegovy® not long after its launch and has increasingly struggled to produce enough of the drug to avoid product shortages and interruptions in therapy as demand for the medication has increased. In 2023, Novo responded to these shortages by expanding its production capacity, and they plan to continue gradually expanding production of Wegovy® starter doses and all dose strengths in 2024. Executives at Novo said this expanded supply chain will provide the necessary inventory of Wegovy® to avoid interruption of treatment for patients prescribed this drug. With the recent entry of a competing drug, Zepbound™ (tirzepatide), into the market, growth in the demand for Wegovy® is not expected to continue at the same rate which should allow the increasing supply to catch up to demand.
Gralise® (gabapentin)
Indication: Once-daily tablets for the management of postherpetic neuralgia (PHN), a form of nerve pain that can follow a shingles outbreak
Dosage Form/Strength: 300 and 600 mg tablets
Average Wholesale Price (AWP): Generic = $345 | Brand = $383
