Your source for the latest industry trends and drug information news.
Volume 6 | Issue 18
September 15, 2024
Contributors:
Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Salome Mawi, PharmD/MBA Candidate and Xintian Wu, PharmD/MBA Candidate
On August 13, 2024, the U.S. Food and Drug Administration (FDA) approved Nemluvio® (nemolizumab) for the treatment of adults with prurigo nodularis. Prurigo nodularis is a chronic skin disease in which the immune system attacks the nervous system, resulting in intensely itchy skin, nodules that can cover large areas of the body and impaired sleep quality. It affects up to 181,000 people in the United States. Topical therapies are often prescribed but may have limitations on duration of use or side effects. Developed by Galderma, Nemluvio® is monoclonal antibody that specifically inhibits signaling of IL-31, a protein produced by the body that drives the itching, inflammation and hardening of the skin associated with prurigo nodularis. Nemluvio® is injected under the skin and is administered every 4 weeks. It is supplied in a prefilled pen, and patients and caregivers may self-inject after proper training by their health care provider.
The approval of Nemluvio® is based on clinical trials involving more than 500 patients with prurigo nodularis. The results showed rapid reduction in itch observed at week 4 and a meaningful improvement in itch, sleep disturbance and skin nodule clearance at week 16. The most common side effects include headache and skin rashes, such as eczema.
On August 8, 2024, B. Braun Medical Inc. issued a voluntary recall of two lots of 0.9% Sodium Chloride for Injection. The recall was initiated due to potential for particulate matter and fluid leakage in the 1-liter plastic intravenous (IV) bags. Use of the affected product could cause emboli in the bloodstream if the particulate matter is not sterile. These emboli could lead to stroke or blockage of blood supply to other organs, resulting in permanent damage or impairment of organ function that could be life-threatening.
One-liter IV bags of 0.9% Sodium Chloride are a source of electrolytes and water for hydration and are indicated for fluid replacement. The affected product lots are J2L763 and J2L764 and have an expiration date of March 31, 2025. They were accidentally distributed domestically in February 2024 prior to completion of all required product testing. To date, there have been no customer complaints or reports of serious injury or death associated with this recall. Adverse reactions or quality problems associated with the product should be reported to the FDA’s MedWatch Adverse Event Reporting program.
In August, the FDA granted emergency use authorization (EUA) for three updated COVID-19 vaccines for 2024-2025 to target the currently circulating Omicron variant JN.1 strain of SARS-CoV-2. Two mRNA vaccines, Comirnaty® and Spikevax®, were approved on August 22, and the updated version of Novavax was approved on August 30. Patient age, product selected, and prior COVID-19 vaccination history all impact the number of doses that should be administered, with previously vaccinated individuals over 12 years only requiring a single injection. Side effects for the updated vaccines are similar to those seen with previous COVID-19 vaccines such as weakness, injection site pain, headache, chill and fever. As in prior years, the vaccines will be available in both pharmacies and healthcare facilities. .
New Drug: Lazcluze™ (lazertinib)
Oral tablets approved, in combination with amivantamab, for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific mutations. [08/19/2024- Janssen Biotech Inc.]
New Drug: Pavblu™ (aflibercept-ayyh)
Injection administered into the eye, approved as a biosimilar to EYLEA® for the treatment of patients with neovascular age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR) by lowering the level of vascular endothelial growth factor (VEGF) and slowing the growth of abnormal blood vessels in the eye. AMD, RVO, DME and DR are all vascular retinal diseases that can cause vision impairment and vision loss if not managed appropriately. [08/23/2024 – Amgen Inc.]
Lucemyra™ (lofexidine)
Indication: For management of opioid withdrawal symptoms during the abrupt discontinuation of opioid use in adults.
Dosage Form/Strength: 0.18 mg tablets
Average Wholesale Price (AWP): Generic = $1,891 | Brand = $3,151
