Your source for the latest industry trends and drug information news.
Volume 7 | Issue 9
May 1, 2025
Contributors:
Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Salome Mawi, PharmD/MBA Candidate and Xintian Wu, PharmD/MBA Candidate
On April 15, 2025, the U.S. Food and Drug Administration (FDA) approved the expanded use of Isturisa® (osilodrostat) for the treatment of elevated cortisol levels in adults with Cushing’s syndrome, specifically when surgery is not possible or has not fully worked. Isturisa® was originally approved by the FDA in 2020 for the treatment of adult patients with Cushing’s disease, a type of Cushing’s syndrome. Elevated cortisol levels as a result of Cushing’s syndrome can be associated with weight gain, high blood sugar, high blood pressure, and weakened bones. If left untreated, these problems can progress into diabetes, heart issues, and infections. Isturisa® helps to reduce the amount of cortisol the body makes by blocking an enzyme involved in its production.
Safety and efficacy for this expansion was evaluated in the LINC6 trial which enrolled 106 patients in the US, France, and Germany. At 3 months, 71.4% of patients treated with Isturisa® had normal cortisol levels in their urine, 69.2% of patients had normal cortisol levels in their blood, and 50% of patients had normal cortisol levels in their saliva. Common side effects include very low cortisol levels, tiredness, nausea, headache, and swelling of the legs or ankles.
On April 14, 2025, Novo Nordisk issued a safety warning to the public that the U.S. drug supply chain contained several hundred units of counterfeit Ozempic® (semaglutide) 1 mg injection products. Ozempic is an injectable medication that is indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. The counterfeit products were not distributed through the Novo Nordisk authorized supply chain. The products were seized by the FDA on April 9th, prior to the safety warning, as use of counterfeit products may pose health risks to patients since contents and quality are not assured.
The affected products are designated with a lot number of PAR0362 and a serial number starting with the first eight digits 51746517. Products should only be considered counterfeit if both numbers are present on the packaging as PAR0362 is an authentic lot number from Novo Nordisk. The FDA and Novo Nordisk are testing the seized products and do not yet have information about their identity, quality or safety. Novo Nordisk is advising customers, retail pharmacies, and health care professionals to check Ozempic® products before use. Consumers with the affected product should immediately stop using it and return it to the place of purchase. Adverse events should be reported to the FDA's MedWatch Adverse Event Reporting program. To date, six adverse event reports are associated with this lot, however none of them appear to be associated with the counterfeit product.
On April 8, 2025, the FDA approved Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for the first-line treatment of unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer in patients 12 years or older. These two specific colorectal cancers are a subtype characterized by impaired DNA repair function, leading to a high mutation burden and poor response to traditional therapy.
The safety and efficacy of combination treatment with Opdivo® and Yervoy® were evaluated in CHECKMATE, a Phase 3, randomized, multicenter, open-label trial, comparing the combination of Opdivo® plus Yervoy® with Odivo® alone or other traditional chemotherapy regimens. The results of the combination demonstrated a reduction in the risk of disease progression or death by 38% when compared to Opdivo monotherapy and by 79% compared to traditional chemotherapy regimens. Common side effects are fatigue, nausea, diarrhea, itchiness, abdominal pain, and muscle pain. This approval provides a new option for these difficult to treat cancers and becomes the ninth gastrointestinal indication for an Opdivo-based regimen.
New Drug: Jobevne™ (bevacizumab-nwgd)
Intravenous injection approved as a biosimilar to Avastin® for the treatment of metastatic colorectal cancer, non-small cell lung cancer, cervical cancer and glioblastoma, a type of brain tumor. It is also indicated for use in combination with other drugs to treat additional forms of cancer. [4/9/2025 - BIOCON BIOLOGICS INC]
Brilinta® (ticagrelor)
Indication: To reduce the risk of cardiovascular death, heart attack, or stroke in patients with coronary artery disease (CAD) or a history heart attack, stroke, or mini-stroke (transient ischemic attacks).
Dosage Form/Strength: 90mg tablets
Average Wholesale Price (AWP): Generic = $185 | Brand = $558
