Monthly Archives: October 2023

FDA Approves Agamree (vamorolone) for the Treatment of Duchenne Muscular Dystrophy

Catalyst Pharmaceuticals, Inc. has reported that Santhera Pharmaceuticals has obtained U.S. Food and Drug Administration (“FDA”) approval for Agamree® (vamorolone) oral suspension 40 mg/mL for use in treating Duchenne Muscular Dystrophy (DMD) in patients aged two years and older.

Agamree offers a novel corticosteroid treatment option for DMD, addressing a significant unmet medical need.

Agamree was granted Orphan Drug and Rare Pediatric Disease designations status for DMD in the U.S. and will be eligible for seven years of orphan drug exclusivity upon approval date and has issued pending patents that could provide protection until 2040.

In July 2023, Catalyst secured the exclusive North American license and commercial rights for Agamree from Santhera for DMD and other potential indications, bolstering its neuroscience commercial portfolio with a highly synergistic neuromuscular asset. As part of that transaction, Santhera will promptly transfer the approved New Drug Application for Agamree to Catalyst. The company plans to launch the product in Q1 2024.

Agamree’s unique mode of action is based on differential effects on glucocorticoid and mineralocorticoid receptors and modifying further downstream activity and, as such, is considered a novel corticosteroid with dissociative properties in maintaining efficacy, with a better-tolerated side effect profile. This mechanism of action may allow vamorolone to emerge as an effective alternative to the current standard of care corticosteroids in children, adolescents, and adult patients with DMD.

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FDA Approves Omvoh (mirikizumab-mrkz), a First-in-Class Treatment for Adults with Moderately to Severely Active Ulcerative Colitis

Eli Lilly and Company has announced today that the U.S. Food and Drug Administration

(FDA) has approved Omvoh™ (mirikizumab-mrkz) (infusion300 mg/15 mL)/injection (100mg/mL), the first and only interleukin-23p19 (IL-23p19) antagonist for the treatment of moderately to severely active ulcerative colitis (UC) in adults.

Marking a significant milestone, Omvoh is the only UC treatment that selectively targets the p19 subunit of IL-23, which plays a role in inflammation related to UC.

The approval was based on results from the LUCENT program, which included two randomized, double-blind, placebo-controlled Phase 3 clinical trials consisting of one 12-week induction study (UC-1) and one 40-week maintenance study (UC-2) for 52 weeks of continuous treatment. All patients in the LUCENT program had past treatments, including biologic treatments, that did not work, stopped working or that they could not tolerate.

Omvoh is indicated for the treatment of moderately to severely active ulcerative colitis in adults. Omvoh is contraindicated in patients with a history of serious hypersensitivity reaction to mirikizumab-mrkz or any of the excipients.

Omvoh will be available in the United States in the coming weeks. Lilly received approval for Omvoh in Japan and the European Union this year and expects regulatory decisions in additional markets around the world in the coming months.

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Exela Pharma Sciences, LLC, (Exela) is voluntarily recalling the products listed in the table below to the consumer level. Particulate matter identified as silicone was observed during routine inspection of retain samples.

Risk Statement: Administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material. If the particulate matter reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. Exela has not received any reports of adverse events related to this recall.

8.4% Sodium Bicarbonate Injection USP is used for treatment of metabolic acidosis and is packaged in a 50 mL glass single dose vials, 20 vials per carton Exela brand (Carton NDC: 51754-5001-5; Vial NDC: 51754- 5001-1, Figure 1) and 25 vials per carton Exela brand (Carton NDC: 51754-5001-4; Vial NDC: 51754-5001-1) and Civica brand (Carton NDC: 72572-740-20; Vial NDC: 72572-740-01, Figure 2).

The affected 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL lots (covering both Exela and Civica brands) include the following lot numbers and expiration dates:

Product was distributed nationwide to wholesalers, distributors, and health systems between January 18,
2022, and February 15, 2023.

Midazolam in 0.8% Sodium Chloride Injection is used for sedation and is packaged in a 100 mL glass vial, 25 vials per corrugated shipper. The vials are labeled with Exela brand (Carton NDC: 51754-2131- 4; Vial NDC: 51754-2131-1, Figure 3).

The affected Midazolam in 0.8% Sodium Chloride Injection 100 mg/ 100 mL include the following lot number and expiration date:

Product was distributed nationwide to wholesalers, distributors, and health systems between July 14, 2023, and September 26, 2023.

ELCYS (cysteine hydrochloride Injection) is used for nutritional requirements per total parenteral nutrition (TPN) and is packaged in a 10 mL glass vial, 10 vials per carton. The vials are labeled with Exela brand (Carton NDC: 51754-1007-3; Vial NDC: 51754-1007-1, Figure 4).

The affected ELCYS (cysteine hydrochloride Injection), USP 50 mg/mL includes the following lot number and expiration date:

The product was distributed nationwide to wholesalers, distributors, health systems, and compounders between July 20, 2023, and August 1, 2023.

Exela is notifying its customers by e-mail and certified mail and is arranging for return and replacement of all recalled product directly to Exela. Customers that have product, which is being recalled should discontinue use, segregate the recalled product, submit a recall stock response form to Exela (even if there is no product to return), and hold the product until shipment instructions are provided by Exela. Customers with questions regarding this recall can contact Exela by phone (828-341-6118) or email at recall@exela.us Monday through Friday, 9:00am – 5:00pm ET. Consumers should contact their physician or healthcare provider if they have experienced any problems related to the usage of this drug product.

(No BeneCard members were affected by this drug recall.)

FDA Reporting
Adverse reactions or quality problems experienced with the use of this product may be reported to the
FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-
1088 to request a reporting form, then complete and return to the address on the pre-addressed
form, or submit by fax to 1-800-FDA-0178

FDA Approves Zymfentra (infliximab-dyyb) Subcutaneous Formulation for the Treatment of People with Inflammatory Bowel Disease

October 23, 2023 — Celltrion USA has announced that the U.S. Food and Drug Administration (FDA) has approved Zymfentra (infliximab-dyyb) for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD) following treatment with an infliximab product administered intravenously. Zymfentra is the first FDA-approved subcutaneous formulation of infliximab.

Zymfentra is a subcutaneous version of Celltrion’s infliximab biosimilar. Zymfentra blocks the action of tumor necrosis factor-alpha (TNF-alpha), a protein that can be overproduced in response to certain diseases and causes the immune system to attack normal, healthy parts of the body. The infliximab biosimilar developed and manufactured by Celltrion was the world’s first monoclonal antibody biosimilar. It is indicated for the treatment of eight autoimmune diseases including Crohn’s disease (CD) and ulcerative colitis (UC). The U.S. Food and Drug Administration approved the biosimilar in April 2016 under the trade name INFLECTRA®.

Zymfentra is a prescription medicine indicated in adults for maintenance treatment of moderately to severely active Crohn’s disease or moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously.

It is not known if Zymfentra is safe and effective for children under 18 years of age.

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From BeneCard PBF staff

Many clients have seen an increase in utilization of GLP-1 receptor agonists such as Ozempic, Saxenda and Wegovy. As the prescribing trends of these medications continue to grow, we are also seeing increased media coverage warning about the risk of side effects associated with these agents. Benecard is committed to ensuring safe and appropriate utilization of these medications. Here are some important facts that you should know:

What are Glucagon-like peptide 1 (GLP-1) receptor agonists and how do they work?

GLP-1 receptor agonists bind to the GLP-1 receptor and work by mimicking GLP-1, a hormone that’s naturally made by the body. GLP-1 agents stimulate glucose-dependent insulin release which leads to a reduction of blood glucose. GLP-1 agonists also slow the passage of food through the stomach which helps people feel full longer, leading to weight loss.

How are these agents accessible?

GLP-1 receptor agonists have been used to treat type 2 diabetes for more than 15 years and for the
treatment of obesity for eight years.
• Saxenda (liraglutide) and Wegovy (semaglutide) are GLP-1 receptor agonists that are FDA approved for chronic weight management.
• Ozempic (semaglutide, injectable), Rybelsus (semaglutide, oral), Trulicity (dulaglutide), and Victoza (liraglutide) are GLP-1 receptor agonists that are FDA approved for patients with type 2 diabetes.
• Mounjaro (tirzeptatide) is a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist (GIP/GLP-1 RA), which is FDA approved for patients with type 2 diabetes.

What are the risks associated with utilization of GLP-1s?

• The most common side effects are gastrointestinal, including nausea, diarrhea, and vomiting. These adverse effects are generally mild to moderate for most patients and improve over time. GLP-1s cause a delay in gastric emptying, but in rare cases, this has resulted in more severe side effects such as gastroparesis (stomach paralysis) and cyclic vomiting. Gastroparesis is a condition that affects the nerves and muscles of the stomach and leads to food sitting in the stomach for too long.

Gastroparesis can have many causes, including diabetes, which makes it difficult to determine how much of a role these drugs play in affecting patients who have reported these side effects. It is believed that reports of extreme side effects such as gastroparesis could be a result of the drug worsening existing “slow stomach” that patients may have but have been unaware of. The FDA says that the benefits of the medication may still outweigh the risks even for this population. Due to the known delay in gastric emptying that GLP-1s cause, the American Society of Anesthesiologists has recently released interim guidance that suggests that patients who are undergoing elective surgery should stop taking these medications at least 1 week prior to surgery, to reduce the risk of nausea, vomiting, and aspiration while under anesthesia.

• GLP-1s also include a warning about suicidal behavior and ideation. The prescribing information for these agents includes a recommendation that patients should be monitored for depression or suicidal thoughts and that therapy should be discontinued if symptoms develop. It is important that patients and prescribers are aware of this recommendation to ensure that they are aware of signs and symptoms of depression, if they should occur.

• Social media influence and celebrities who are promoting the use of GLP-1 agents in addition to drug shortages have contributed to an increase in off-label use and unauthorized versions of these drugs. The FDA has warned that there are potential safety risks associated with using “compounded” GLP-1s, which are now gaining popularity.

• GLP-1s are contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Patients taking GLP-1s should be monitored for symptoms of hypoglycemia, acute pancreatitis, gallbladder disease, and kidney injury.

Benecard’s Continued Commitment to Patient Safety

BeneCard PBF now conducts clinical reviews on all GLP-1 medications to ensure that the appropriate medication is being prescribed for its intended FDA approved use. GLP-1 agents for the treatment of obesity require initial clinical review and continued reauthorizations to ensure that the appropriate dose titration schedule is being followed and that patients are being monitored for unwanted side effects.

Reviews of updated safety data and recommendations are conducted so that, as new safety concerns for these agents arise, we can add these new monitoring parameters or warnings to our clinical review policies. Patient safety and quality healthcare for the patient are always our top priorities.

References

Goodman, B 2023, ‘They took blockbuster drugs for weight loss and diabetes. Now their stomachs are paralyzed’, CNN Health, 25 July, accessed 15 August 2023, They took blockbuster drugs for weight loss and diabetes. Now their stomachs are paralyzed | CNN

Redmond, K 2023, ‘Potential Wegovy, Ozempic link to suicidal thoughts prompts EU investigation’, NJBIZ, 14 July, accessed 15 August 2023, Potential Wegovy, Ozempic link to suicidal thoughts prompts EU investigation – NJBIZ

Constantino, A 2023, ‘People should stop taking Ozempic, Wegovy obesity drugs before surgery, doctors group says’, CNBC, 30 June, accessed 15 August 2023, Stop taking Ozempic, Wegovy before surgery: Doctors (cnbc.com)

KVK-Tech, Inc. is voluntarily recalling one lot (Batch Number: 17853A of Betaxolol Tablets, USP 10 mg, White, Round, film coated biconvex tablets, debossed “K” above bisect “13” on one side and plain on the other side” to the consumer level. The batch was distributed nationwide to wholesalers and retailers. The batch is being recalled as a precautionary measure due to a single Oxycodone HCl tablet 5 mg foreign tablet found on the packaging line during the line clearance, after the subject batch was packaged. KVK has not received any reports of foreign tablets in any bottle of Betaxolol Tablets, USP 10 mg (Batch Number 17853A).

Risk Statement: The betaxolol package insert warns about slowing in the heart rate in elderly patients which is likely to be exacerbated by inadvertent opioid administration. Additionally, some patients prescribed low-dose betaxolol might have compromised heart and lung function that is also likely to be exacerbated by an opioid. Furthermore, there are minor differences in appearance between betaxolol 10 mg tablets and oxycodone 5 mg tablets, not likely to be noticed by a regular user of the 10 mg betaxolol tablet. Specific patient populations such as those with opioid use disorder (OUD) or at risk of OUD, infants, children, and the elderly are likely to be negatively affected by inadvertently receiving an opioid, especially if a substantial number of oxycodone tablets have been introduced into a bottle labeled as betaxolol.

Therefore, inadvertent exposure to a controlled substance, such as oxycodone, in that patient population is likely to result in significant slowing in breathing, known as respiratory depression, which is a serious health risk.

Betaxolol HCl Tablets are packaged in 50 CC White High-Density Polyethylene (HDPE) bottles, 100 Tablets and 10702-013-01. The affected Betaxolol Tablets, USP 10 mg lot 17853A has labeled expiration as June 2027. The product can be identified by using the images of tablets and labels provided below.

KVK notified its distributors and customers by a Recall Notification Letter via email and FedEx overnight mail on 09/26/2023 and is arranging for the return of all recalled products. KVK believes that a small number of bottles may have been distributed to retail pharmacies. Consumers that may have received Betaxolol Tablets, USP 10 mg (Batch Number: 17853A), should stop using and immediately return the product to KVK-Tech, Inc., 110 Terry Drive, Newtown, PA 18940. KVK will arrange to reimburse customers for their costs in purchasing the product.

Consumers with questions regarding this recall can contact KVK-Tech Inc., at (215) 579-1842 Ext: 6002 Monday – Friday, 8:00 am – 6:00 pm EST or by email at customerservice@kvktech.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

No clients/members of BeneCard PBF were affected by these recalls.

FDA Reporting

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
• Complete and submit the report Online: www.fda.gov/medwatch/report.htm

• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-
1088 to request a reporting form, then complete and return to the address on the pre-addressed
form, or submit by fax to 1-800-FDA-0178

FDA Approves Penbraya (meningococcal groups A, B, C, W and Y vaccine) for the Prevention of the Five Most Common Serogroups Causing Meningococcal Disease in Adolescents

Pfizer Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved Penbraya™ (meningococcal groups A, B, C, W and Y vaccine), the first and only pentavalent vaccine that provides coverage against the most common serogroups causing meningococcal disease in adolescents and young adults 10 through 25 years of age. Penbraya combines the components from two meningococcal vaccines, Trumenba® (meningococcal group B vaccine) and Nimenrix® (meningococcal groups A, C, W-135, and Y conjugate vaccine) to help protect against the five most common meningococcal serogroups that cause most invasive meningococcal disease (IMD) globally.

Meningococcal disease is an uncommon but serious illness that can lead to death within 24 hours and, for survivors, can result in life-altering, significant long-term disabilities. Penbraya reduces the total number of doses needed for individuals to be fully vaccinated against the five most common serogroups, thereby streamlining the standard of care, and potentially increasing the number of adolescents and young adults vaccinated.

According to the U.S. Centers for Disease Control and Prevention (CDC), combining vaccines into fewer shots may mean that more adolescents and young adults get their recommended vaccines on time, resulting in fewer delays in protection against serious diseases. Routine use of Penbraya could also reduce IMD cases and associated mortality, the rate of long-term consequences of infection (sequelae) in survivors and costs associated with controlling outbreaks.

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