Your source for the latest industry trends and drug information news.
Volume 6 | Issue 13
July 1, 2024
Contributors:
Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Gabrielle Graca, PharmD/MBA Candidate and Salome Mawi, PharmD/MBA Candidate
On June 10, 2024, the U.S. Food and Drug Administration (FDA) approved Iqirvo® (elafibranor) tablets for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA alone, or as monotherapy in patients who are unable to tolerate UDCA. PBC is a rare autoimmune liver disease caused by a build-up of bile acids and chronic inflammation that leads to liver scarring and dysfunction in around 100,000 Americans. If PBC is not properly treated, it can lead to liver failure and death. Iqirvo® is a first-in-class oral peroxisome proliferator-activated receptor (PPAR) agonist that is taken once daily. In a clinical trial, Iqirvo® demonstrated superior efficacy in treating PBC compared to placebo, with or without UDCA. A significantly greater number of patients in the medication group achieved a reduction in alkaline phosphatase (ALP), a liver enzyme often elevated in liver disease. Some common adverse reactions with Iqirvo® include weight gain, abdominal pain, diarrhea, nausea and vomiting. This medication was granted accelerated approval by the FDA for the treatment of PBC, with or without UDCA.
On June 5, 2024, HomeoCare Laboratories Inc. announced a voluntary recall of two batches of Homeopathic StellaLife Oral Care Products due to microbial contamination. The FDA found that StellaLife Advanced Formula Peppermint Vega Oral Care Rinse had higher than acceptable levels of total aerobic microbial count (TAMC). The product has an associated lot number of 2550 and an expiration date of 2/2026. Additionally, Bacillus species were found in StellaLife Vega Unflavored Oral Spray (lot number 2552, expiration date 2/2026). Microbial contamination could result in severe or life-threatening adverse events in immunocompromised patients. To date, there have been no adverse events related to this recall. Dental practices are advised to stop dispensing these products and arrange returns for the recalled lots. Consumers with the recalled products should immediately stop using the products and discard or return them to the place of purchase. Consumers should contact their health care provider if any problems arise after using any of these recalled batches. Adverse effects should be reported to the FDA’s MedWatch Adverse Event Reporting program.
On July 17, 2024, Merck announced the FDA approval of Capvaxive™ (Pneumococcal 21-Valent Conjugate Vaccine) for the prevention of pneumococcal pneumonia and invasive pneumococcal disease (IPD) in adults caused by Streptococcus pneumoniae (S. pneumoniae). Pneumococcal pneumonia is the most common presentation of pneumonia, with symptoms such as fever, cough, shortness of breath and chest pain. It is estimated that over 150,000 adults are hospitalized each year in the U.S. due to pneumococcal pneumonia. IPD can occur in various locations in the body, causing serious clinical syndromes such as bacteremia (infection in the bloodstream) or meningitis (infection of the coverings of the brain and spinal cord). IPD can lead to hospitalization, organ damage and even death.
There are approximately 100 different strains of S. pneumoniae. Capvaxive™ is administered as a single dose and covers 21 of these, 8 of which are unique and not covered by other approved pneumococcal vaccines. In clinical studies, it was found that Capvaxive™ was as effective and has a comparable safety profile as other available pneumococcal vaccines. Common adverse reactions included injection site pain, fatigue and headache. Capvaxive™ was granted Priority Review by the FDA.
New Drug: Approvals
New Drug: Rytelo™ (imetelstat)
Intravenous injection indicated for the treatment of adult patients with low- to intermediate-risk myelodysplastic syndromes (MDS) with anemia that requires transfusion of 4 or more red blood cell units over 8 weeks and who have not responded to, have lost response to or are ineligible for erythropoiesis-stimulating agents. MDS are disorders in which the bone marrow fails to produce enough healthy blood cells. [6/6/2024 – Geron]
New Indication: Kevzara® (sarilumab)
Subcutaneous injection approved for the treatment of active polyarticular juvenile idiopathic arthritis in patients who weigh 63 kg (139 lbs) or greater. [6/10/2024 – Sanofi]
Ala-Scalp® (hydrocortisone)
Indication: Topical steroid for the relief of redness, itching, swelling and discomfort caused by skin conditions.
Dosage Form/Strength: 2% lotion
Average Wholesale Price (AWP): Generic = $2,400 | Brand = $1,101
*The generic is indeed entering the market at a more expensive cost than the co-licensed brand products.
