PDR Drug Update - February 2024

Attacking ASCVD via an Anti-inflammatory Approach

February is American Heart Month, giving a much-needed spotlight to all manner of heart health topics. One area of focus with an interesting recent advancement is a first-ever FDA approval for an anti-inflammatory therapeutic agent for cardiovascular disease. The new approval gives prescribers an entirely new method for treating atherosclerotic cardiovascular disease (ASCVD). It is a new step in care that has the potential to help reduce overall morbidity with ASCVD.

Cardiovascular disease is responsible for one death every 33 seconds in the US, according to statistics provided by the CDC. The number of patients who are estimated to have ASCVD is nearing 30 million. It is the leading cause of death for all adults, regardless of gender or race. These patients are at high risk for recurring acute cardiovascular events. The plaque that builds up in arteries causes narrowing and hardening, leading to heart attacks and strokes. Lipid-lowering therapies, lifestyle changes, and risk reduction are all vital parts of the arsenal clinicians make use of to help lower the chances for patients to experience life-threatening cardiac events. However, many patients have unique or difficult-to-manage risk drivers that keep them in a precarious position in relation to their disease. What may help is to incorporate therapy that treats the disease from a new angle. This approach addresses underlying inflammation that exists in ASCVD.

COVID-19 has been known to ignite a substantial inflammatory response in patients, so more attention and research have focused on inflammation in recent years. The increased awareness benefits patients and providers alike, as it can aid in accepting and incorporating new therapeutic approaches into traditional methods. Treatment with statins and blood-pressure control is the familiar, recognized path, and now there is a new choice to add as a next step—Lodoco (colchicine), available as a 0.5mg tablet.

Colchicine itself is not a new pharmacological agent. Its origins are ancient, with its anti-inflammatory properties recognized for thousands of years. It is an alkaloid originally derived from the flower Colchicum autumnale and has long been used to treat gout and familial Mediterranean fever. Colchicine’s ability to disrupt cytoskeletal functions, preventing microtubule assembly, has been beneficial as an anti-inflammatory within joints when uric acid changes to a crystal form, resulting in gouty arthritis. When cholesterol changes into atherosclerotic plaque, its irritating crystalline form also causes problematic inflammation, and the administration of colchicine has been shown to be effective in reducing this issue.

Lodoco received a broad approval from the FDA, with its indication covering the reduction of risk for myocardial infarction, stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease. The approval of the low-dose form of colchicine was granted after it was proven in clinical trials to reduce the risk of cardiac events in adult patients with established ASCVD by an additional 31% on top of the existing standard of care. The modest dosing of 0.5mg colchicine per day was well tolerated by patients. It is contraindicated in patients with pre-existing blood dyscrasias, renal failure, and severe hepatic impairment. It cannot be taken by those already prescribed strong CYP3A4 inhibitors or P-gp inhibitors due to reports of fatal colchicine toxicity in these patients.

Being able to address residual inflammation under the approval for Lodoco places clinicians in a good position to explore pharmacological options that complement each other. Colchicine seems like it will be synergistic with statin therapy and could evolve to be a standard for all or most patients, in conjunction with statins. Stay informed about critical drug information, including treatment options for cardiovascular disease, by exploring PDR by ConnectiveRx. You can also stay current by using the official PDR app, mobilePDR, which is available for free from your preferred app store.

FDA New Indications

Adbry

The FDA has approved an expanded indication for Adbry (tralokinumab-ldrm) for patients aged 12 to 17 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or for whom those therapies are not advisable. Learn more about Adbry

Balversa

The FDA has approved Balversa (erdafitinib) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma with susceptible fibroblast growth factor receptor 3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. Learn more about Balversa

Casgevy

The FDA has approved Casgevy (exagamglogene autotemcel) for the treatment of transfusion-dependent β-thalassemia in patients aged 12 years and older. Learn more about Casgevy

Hyqvia

The FDA has approved Hyqvia (immune globulin infusion 10% [human] with recombinant human hyaluronidase) for the treatment of chronic inflammatory demyelinating polyneuropathy as maintenance therapy to prevent the relapse of neuromuscular disability and impairment in adults. Hyqvia first received approval in 2014 for the treatment of primary immunodeficiency in adults, which has since been expanded to include children aged 2-16 years. Learn more about Hyqvia

Nexletol

The FDA has approved an updated indication for Nexletol (bempedoic acid) tablet to include treatment of primary hyperlipidemia as a qualifier for existing approved populations. Learn more about Nexletol

Nexlizet

The FDA has approved an updated indication for Nexlizet (ezetimibe) tablet to include treatment of primary hyperlipidemia as a qualifier for existing approved populations. Learn more about Nexlizet

Wilate

The FDA has approved an expanded indication for Wilate (von Willebrand factor/coagulation factor VIII complex [human]) lyophilized powder for solution for intravenous injection. The approved label now includes routine prophylaxis aimed at reducing the frequency of bleeding episodes in adults and children aged 6 and older with any type of von Willebrand disease. Learn more about Wilate

FDA Recalls

Hospira Injectable Products

Hospira, Inc. is voluntarily recalling certain lots of 4.2% sodium bicarbonate injection, USP Abboject glass syringe, 5mEq/10mL; 8.4% sodium bicarbonate injection, USP Lifeshield Abboject glass syringe, 50mEq/50mL; and atropine sulfate injection, USP Lifeshield Abboject glass syringe, 1mg/10mL, to the user level. The recall was initiated due to the potential for presence of glass particulate matter, identified during product inspection. Learn more about the Hospira injectable products recall

Kilitch Healthcare India Limited Ophthalmic Products

Kilitch Healthcare India Limited is issuing an amendment to its press release from November 2023. There are corrections for two of the issued NDCs. Lubricant gel drops 15mL, carboxymethylcellulose sodium eye drops 1.0% W/V was incorrectly listed as 1822-9706-5 and should be 11822-4540-5. Lubricant eye drops 15mL (twin pack), carboxymethylcellulose sodium eye drops 0.5% W/V was incorrectly listed as 11822-9707-5 and should be 11822-4811-5. Learn more about the Kilitch Healthcare India Limited ophthalmic products recall

Leiters Health IV Bag Products

Leiters Health is voluntarily recalling 33 lots of products, to the user level. The recalled batches of vancomycin IV bags, phenylephrine IV bags, and fentanyl IV bags are being recalled due to the potential for superpotency because they may contain twice the labeled amount of drug. Learn more about the Leiters Health IV bag products recall

FDA Alerts

Naloxone Nasal Spray

The FDA is announcing that Emergent BioSolutions is extending the shelf-life of newly manufactured Narcan (naloxone HCl) 4mg nasal spray products from 3 to 4 years. This action was taken at the request of the FDA. Learn more about the naloxone nasal spray alert

Promethazine HCl Injection Products

The FDA is alerting healthcare professionals of labeling updates intended to further reduce the risk of severe chemical irritation and tissue damage from intravenous administration of promethazine HCl injection. The FDA recommends administration of promethazine HCl injection by deep intramuscular administration instead of intravenous administration. Learn more about the promethazine HCl injection products alert

Severe Hypocalcemia Risk with Prolia

The FDA has concluded that the osteoporosis medicine Prolia (denosumab) increases the risk of severe hypocalcemia in patients with advanced chronic kidney disease, particularly patients on dialysis. The FDA has added a Boxed Warning to the Prolia prescribing information about the risk. Learn more about the severe hypocalcemia risk with Prolia drug safety communication

Suicidal Thoughts or Actions in Patients Taking GLP-1 RAs

The FDA has been evaluating reports of suicidal thoughts or actions in patients treated with a class of medicines called glucagon-like peptide-1 receptor agonists (GLP-1 RAs). Its preliminary evaluation does not suggest a causal link. The Agency will communicate its conclusions and recommendations after it completes its review or has more information to share. Learn more about the suicidal thoughts or actions in patients taking GLP-1 RAs drug safety communication

February 2024