Your source for the latest industry trends and drug information news.
Volume 4 | Issue 20
October 15, 2022
Contributors:
Chief Authors: Rebecca Waite, PharmD, Bonnie Broczkowski, PharmD & Colleen Peehler, PharmD
Contributing Authors: Yi (Eve) Zheng, PharmD/MBA Candidate, Gabrielle Graca, PharmD/MBA Candidate
On September 29, 2022, the U.S. Food and Drug Administration (FDA) approved RelyvrioTM for the treatment of Amyotrophic Lateral Sclerosis (ALS). ALS, commonly referred to as Lou Gehrig’s disease, is an incurable disease characterized by the destruction of nerve cells that control voluntary muscles needed for movements such as walking, talking, and breathing. The disease typically results in death from respiratory failure within 3 to 5 years from symptom onset and is estimated that approximately 20,000 Americans are living with ALS. RelyvrioTM (sodium phenylbutyrate/taurursodiol) was approved based on a clinical trial that demonstrated slower decline in daily functioning and improved overall survival in subjects taking the drug compared to placebo. Adverse events seen in the study included diarrhea, abdominal pain, nausea and upper respiratory tract infection. RelyvrioTM is formulated in a packet that is to be combined with 8 ounces of water and taken by mouth daily for 3 weeks and then twice daily thereafter. The FDA granted a priority review of RelyvrioTM and has designated it as an orphan drug.
On September 29, 2022, Golden State Medical Supply issued a recall due to a mislabeling issue on some of their medication bottles. Bottles containing clopidogrel 75mg tablets with the lot# GS046745 were incorrectly labeled as atenolol 25 mg tablets. The company has recalled both products with the specified lot number, and wholesalers immediately stopped distribution. Individuals are prescribed atenolol to lower their blood pressure. If patients were to start taking clopidogrel instead of their prescribed atenolol, they would be at increased risk of cardiac adverse effects, elevated blood pressure and bleeding. The risk of bleeding could be especially serious if the patient was already taking clopidogrel or another blood-thinning medication. To date, there have been no reports of adverse events related to the recalled products.
On September 30, 2022, the FDA released a statement describing their plan to promote the long-term stability of the supply chain of infant formula across the United States and to maintain a consistent supply of a variety of products. To do so, the FDA will continue to exercise enforcement discretion for formula manufacturers meeting predetermined criteria. Enforcement discretion allows the FDA to elect to suspend enforcement of certain approval requirements when the risk is low to patients. Manufacturers under this guidance will be allowed to market and import certain formulas while they work to meet all U.S. regulatory requirements. The goal of this policy is to diversify the sources of infant formula so that it is less likely to affect consumers should there be disruption in production from one or more manufacturers. To date, the FDA has issued 16 enforcement discretion letters to eight companies in nine countries, resulting in an increase in supply that is available to U.S. consumers. The initial enforcement discretion guidance announced in May 2022 to address the baby formula shortage was set to expire on November 14, 2022, but has since been extended to January 6, 2023, and may be extended longer if needed. It is worth noting that all companies that market infant formula in the U.S., including the eight companies who received enforcement discretion letters, must comply with all regulations such as safety, nutrient adequacy, labeling and packaging requirements. The FDA has stated that consumers should have the utmost confidence in the infant formula that is being marketed. Even with enforcement discretion, companies are still subject to inspection and must provide the FDA with details about the product’s nutritional adequacy and safety, microbiological testing, labeling information and manufacturing facility practices. There are educational resources and videos available to consumers who are interested in learning more about this topic.
Novel Drug Approval: Omlonti® (omidenepag isopropyl)
Ophthalmic solution approved for the reduction of pressure inside the eye for patients with open-angle glaucoma or ocular hypertension [9/22/22 – SANTEN, INC.]
New Indication: AponvieTM (aprepitant)
Injectable emulsion approved for the prevention of postoperative nausea and vomiting in adult patients. [9/16/22 – HERON THERAPEUTICS, INC.]
Gilenya® (fingolimod hydrochloride) capsules
Indication: Multiple sclerosis
Dosage Form/Strength: 0.5mg capsules
Average Wholesale Price (AWP): Generic = $351 | Brand = $390
