Subscribe
Share
Share
Embed
The "Monthly Update" Podcast from Drugs.com delivers monthly roundups of new drug approvals, updated indications, safety alerts, and the latest healthcare news.
Welcome to the August 2026 edition of Drugs.com Monthly Update, where we bring you some of the latest FDA approvals. This episode uses AI tools to help with formatting, organisation, and narration. All content has been reviewed by a senior editorial pharmacist.
This month, we delve into some exciting FDA approvals that could significantly impact patient care across multiple specialties. Today, we're covering mFLUSIVA for influenza prophylaxis, Orzeyful for narcolepsy type 1, Genglycos for a rare glycogen storage disease, Rasonque for metastatic pancreatic cancer, and Bixlenvo for HIV-1 management. Let's dive right in.
Let's start with mFLUSIVA, spelled M-F-L-U-S-I-V-A. This new mRNA-based vaccine was recently approved by the FDA to prevent influenza disease caused by influenza A and B subtypes in adults 50 years of age and older. In clinical trials, the vaccine demonstrated relative vaccine efficacy and robust immune responses against confirmed influenza-like illness compared to standard and high-dose active comparators. mFLUSIVA is administered as a single-dose intramuscular injection. When counseling patients, it is important to mention warnings for anaphylactic reactions and Guillain-Barré syndrome, with the most common side effects being injection site pain, fatigue, headache, muscle aches, and chills.
Moving on to sleep medicine, the FDA has cleared Orzeyful, spelled O-R-Z-E-Y-F-U-L. This orexin receptor 2 agonist is indicated for the treatment of narcolepsy type 1, also known as narcolepsy with cataplexy, in adult patients. Global Phase 3 studies showed that this therapy provided statistically significant improvements across the full range of disease symptoms, including enhanced wakefulness and reduced rates of sudden muscle weakness over twelve weeks. It is taken orally as a tablet taken at the same time each day, with the first dose upon awakening and a second dose three to five hours later. Patients and clinicians should be aware of warnings for insomnia and urinary frequency, while common side effects encompass urinary urgency and excessive saliva production.
In the realm of rare genetic conditions, the FDA approved Genglycos, spelled G-E-N-G-L-Y-C-O-S. This adeno-associated virus vector-based gene therapy is approved for adults and children 8 years of age and older with glycogen storage disease type Ia to help reduce daily cornstarch intake. The 48-week Phase 3 GlucoGene study demonstrated a significant reduction in cornstarch requirements for patients receiving the gene therapy compared to those on placebo. Genglycos is administered as a single intravenous infusion following prior premedication with acetaminophen and non-sedating antihistamines. Important safety considerations include hypersensitivity and infusion reactions, adrenal insufficiency, and a theoretical risk of tumorigenicity, while the most common adverse reactions are elevated liver enzymes and nausea.
For oncology, the FDA granted approval for Rasonque, spelled R-A-S-O-N-Q-U-E. This RAS GTPase family inhibitor is indicated for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. The Phase 3 RASolute 302 trial revealed that patients receiving this targeted therapy experienced a 60 percent reduced risk of death and significant improvements in progression-free survival compared to standard chemotherapy. It is taken orally once daily as a tablet, with or without food. Clinicians should monitor for warnings such as severe dermatologic toxicities, mouth ulcers, and interstitial lung disease, with common side effects including rash, diarrhea, nausea, fatigue, and decreased blood cell counts.
Lastly, in infectious diseases, we have Bixlenvo, spelled B-I-X-L-E-N-V-O. This combination of the integrase inhibitor bictegravir and the capsid inhibitor lenacapavir is indicated as a complete regimen for the treatment of HIV-1 in adults to replace their current antiretroviral regimen in those who are virologically suppressed on a stable regimen. Phase 3 ARTISTRY trials established that switching from complex, multi-tablet regimens to this combination therapy maintained virologic suppression effectively at Week 48 without significant impact on weight. Bixlenvo is taken orally as a once-daily tablet, which follows a two-day initiation regimen of Bixlenvo plus oral lenacapavir. The most commonly reported side effects include headache, nausea, and diarrhea.
Thank you for tuning in to the Drugs.com monthly update podcast, where staying informed means staying ahead in your field. We look forward to bringing you more updates next month. Until next time, know more, be sure.