Your source for the latest industry trends and drug information news.
Volume 6 | Issue 15
August 1, 2024
Contributors:
Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Salome Mawi, PharmD/MBA Candidate and Xintian Wu, PharmD/MBA Candidate
On June 26, 2024, the U.S. Food and Drug Administration (FDA) approved Ohtuvayre™ (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults. COPD is a chronic lung disease that includes chronic bronchitis and emphysema, affecting over 390 million people worldwide. Despite existing therapies, many COPD patients continue to experience daily symptoms such as breathlessness and persistent coughing. Ohtuvayre™ is the first inhaled product in over 20 years with a novel mechanism of action for COPD treatment, acting as a selective inhibitor of phosphodiesterase 3 and 4 (PDE3 and PDE4). This dual inhibition provides both an opening of the airways and a reduction of inflammation in the lungs. The treatment is delivered through a standard jet nebulizer.
Approval of Ohtuvayre™ was based on data from the Phase 3 ENHANCE trials, which demonstrated significant improvements in lung function in patients with moderate to severe COPD. The therapy was well tolerated in this population. The most common side effects of Ohtuvayre™ include back pain, high blood pressure, bladder infection and diarrhea. Serious side effects can include sudden breathing problems and mental health issues, such as suicidal thoughts and behavior. Patients with a history of mental health problems or liver impairment, or those who are pregnant or breastfeeding, should inform their health care provider before using Ohtuvayre™. The manufacturer, Verona Pharma, plans to launch Ohtuvayre™ in the third quarter of 2024, and it will be available through a limited number of specialty pharmacies.
On July 16, 2024, Endo, Inc announced a voluntary recall of one lot of clonazepam orally disintegrating 0.25 mg tablets. The product is being recalled due to mislabeling of the cartons where 0.25 mg tablets are labeled as 0.125 mg tablets. However, the blister strips inside the cartons reflect the correct strength of 0.25 mg. Clonazepam is indicated for the treatment of Lennox-Gastaut syndrome, akinetic and myoclonic seizures and panic disorder. Use of the mislabeled product could expose a patient to double the intended dose if they believe they are taking 0.125mg. Using higher doses of clonazepam increases the risk of significant sedation, dizziness, impaired coordination, confusion and respiratory depression.
The recalled clonazepam orally disintegrating tablets are packaged in cartons of 60 tablets. The impacted products are labeled with lot number 550147301. Endo is providing written notification to wholesalers and retailers to arrange for the return of the recalled lot. Consumers with the recalled products should immediately stop using them and contact their health care provider if any problems arise after use. Adverse effects should also be reported to the FDA’s MedWatch Adverse Event Reporting program. To date, Endo has not received any reports of adverse events related to this recall.
On June 27, 2024, the Centers for Disease Control and Prevention (CDC) released their recommendations for vaccination against the COVID-19 and influenza viruses for the upcoming 2024-2025 season. New versions of these vaccines have been developed to target the latest variants of each virus. The CDC recommends anyone over 6 months old get vaccinated to protect against severe outcomes from these two respiratory illnesses, including hospitalization and death. Vaccinations are proven effective in reducing the likelihood of infection and diminishing the severity of illness in those who become infected.
The new COVID-19 and flu vaccines are expected to be available at pharmacies and health care offices by the end of summer. However, it is recommended for most people, especially the elderly and those with compromised immune systems, to wait until September or October to receive both vaccinations to provide the best protection throughout the season. It is possible to receive both vaccinations at one time for convenience.
New Drug: Approvals
New Drug: Vigafyde™ (vigabatrin)
Oral solution approved for the treatment of infantile spasms, a type of seizure that can injure an infant’s developing brain, in pediatric patients 1 month to 2 years old when potential benefits outweigh the risk.[6/17/24 – Pyros Pharms]
New Drug: PiaSky™ (crovalimab-akkz)
Intravenous and subcutaneous (under the skin) injection indicated for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in adults and children 13 years or older who weigh at least 88 pounds. PNH is a rare disorder in which the immune system attacks red blood cells and platelets, increasing the risk of anemia, kidney disease and blood clots. [6/20/24 – Genentech Inc]
Corlanor® (ivabradine)
Indication: For the treatment of symptomatic heart failure to reduce the risk of hospitalization due to worsening of the disease.
Dosage Form/Strength: 5mg & 7.5mg tablets
Average Wholesale Price (AWP): Generic = $659 | Brand = $715
