Your source for the latest industry trends and drug information news.
Volume 6 | Issue 21
November 1, 2024
Contributors:
Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Salome Mawi, PharmD/MBA Candidate and Xintian Wu, PharmD/MBA Candidate
On October 11, 2024, the U.S. Food and Drug Administration (FDA) approved Hympavzi™ (marstacimab-hncq) for the treatment of hemophilia A or B without coagulation factor inhibitors in adults and pediatric patients 12 years and older. Hemophilia is a rare genetic bleeding disorder usually diagnosed in early childhood. The disease inhibits the blood’s ability to clot properly. Individuals with hemophilia experience repeated bleeding episodes inside the joints which can lead to joint damage. Hympavzi™ is approved to prevent or reduce the frequency of bleeding episodes. It is the first and only anti-tissue factor pathway inhibitor (anti-TFPI) with a once-weekly dosing schedule and was granted Orphan Drug designation. It is approved for administration under the skin via a self-administered, pre-filled, autoinjector pen. This is likely to improve compliance and outcomes for patients who currently require routine infusions for preventive care.
The approval of Hympavzi™ was based on results from the Phase 3 BASIS trial. In the trial, Hympavzi™ demonstrated substantial bleed reduction compared to routine prophylaxis (RP) and on-demand (OD) treatment. After a 12-month active treatment period, Hympavzi™ reduced the annualized bleeding rate for treated bleeds by 35% and 92% when compared with RP and OD treatment, respectively. The most common side effects are injection site reactions, headache and itching.
On September 17, 2024, Bionpharma Inc. issued a voluntary recall of one batch of Atovaquone Oral Suspension, 750mg per mL. Atovaquone is an antimicrobial drug indicated for the treatment and prevention of Pneumocystis jirovecii pneumonia. The recall was initiated due to contamination with Cohnella bacteria. Microbial contamination can potentially lead to infections and life-threatening conditions such as inflammation of the heart and permanent soft tissue damage in immunocompromised individuals, which is also the population most likely to be prescribed this medication. The affected batch is associated with lot number 2310083 and has an expiration date of September 30, 2025. It was distributed to wholesalers and retailers in the United States andthere have been no reports of adverse events associated with this recall to date. Biopharma is providing written notification to arrange for the return of the recalled product. Consumers with the affected lot should stop using the product and return to the place of purchase. If any adverse effects are experienced, consumers should contact their health care provider and report it to the FDA’s MedWatch Adverse Event Reporting program.
On October 7, 2024, the FDA authorized Healgen Rapid Check COVID-19/Flu A&B Antigen Test. It is the first over the counter (OTC) combination test for both COVID-19 and flu for at-home use that has gone through the traditional review pathway as opposed to receiving an emergency use authorization. The test kit is intended for individuals who are experiencing respiratory symptoms and use a nasal swab sample to deliver results in approximately 15 minutes for COVID-19 and influenza. The test detects proteins from both SARS-CoV-2, which is the virus that causes COVID-19, and influenza A and B, which are the viruses that cause flu.
The test is recommended for individuals 2 years and older, with people under the age of 14 receiving assistance from an adult. The test is not recommended for individuals under 2 years old. As with all rapid antigen tests, there is a potential risk of false negative test results. Individuals who test negative and continue to experience symptoms including cough, fever and shortness of breath should seek follow up care with their health care provider. Individuals who test positive should take appropriate precautions to avoid spreading the virus and follow up with health care providers.
New Drug: Itovebi™ (inavolisib)
Oral tablets approved, in combination with palbociclib and fulvestrant, for the treatment of adults with a specific type of breast cancer: hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with an abnormal PIK3CA gene, following recurrence during or after hormone therapy. [10/10/24- Genentech Inc]
Roxybond® (oxycodone)
Indication: Treatment for severe pain that requires an opioid analgesic and for which alternative treatments are inadequate.
Dosage Form/Strength: 30mg tablets
Average Wholesale Price (AWP): Generic = $1,270 | Brand = $1,675
