The Drugs.com Monthly Update Podcast

Welcome to the December 2025 edition of Drugs.com Monthly Update Podcast, where we highlight key FDA approvals to keep you updated in your field. This episode uses AI tools to help with formatting, organisation, and narration. All content has been reviewed by a senior editorial pharmacist.

Today we have some exciting approvals to discuss. We'll delve into Wegovy's new oral formulation for weight loss, Myqorzo's benefits for obstructive hypertrophic cardiomyopathy, and much more.

Let’s start with the new tablet formulation of Wegovy, spelled W-E-G-O-V-Y. The FDA has approved this medication as the first oral glucagon-like peptide-1 (GLP-1) receptor agonist for managing obesity in the United States. In clinical trials, adults taking Wegovy achieved an impressive average weight loss of 16.6% over 64 weeks compared to just 2.7% for those on a placebo. This provides a new option for people who have avoided weight loss treatment because they don't want to use injections, though users should be aware of common gastrointestinal side effects and other warnings.

Next, we discuss Myqorzo, spelled M-Y-Q-O-R-Z-O, approved for the treatment of obstructive hypertrophic cardiomyopathy (oHCM) in adults. This condition, which involves the thickening of the heart muscle, often leads to significant symptoms like chest pain and shortness of breath. Myqorzo represents a long-awaited and major addition to oHCM treatment, and is Cytokinetics first FDA approval. In clinical trials, Myqorzo, a cardiac myosin inhibitor, significantly improved exercise capacity, allowing sufferers to tolerate more physical activity with less discomfort. However, the medication comes with a boxed warning for heart failure risk, and a requirement to enroll in the Myqorzo REMS Program, highlighting the need for careful monitoring.

Another significant approval is Exdensur, spelled E-X-D-E-N-S-U-R, a long-acting interleukin-5 (IL-5) antagonist from GSK. Approved as an add-on therapy for treating severe asthma with an eosinophilic phenotype in patients 12 years and older, Exdensur is administered every 6 months by a healthcare provider. Clinical trials report a 48 to 58% reduction in the number of asthma attacks per year with Exdensur compared with placebo. This treatment allows better management of severe asthma with fewer exacerbations. Allergic reactions are possible, and other potential side effects include upper respiratory tract infections and allergic rhinitis.

Let’s turn our focus now to Jaypirca, spelled J-A-Y-P-I-R-C-A. The FDA has extended approval to Lilly of this non-covalent (reversible) BTK inhibitor to include chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) in adults whose conditions have not responded to covalent BTK inhibitors. Patients should be aware of potential side effects, including bleeding, infections, and heart rhythm issues.

In cholesterol management, Lerochol, spelled L-E-R-O-C-H-O-L, joins the scene as a new, third-generation, PCSK9 inhibitor. This medication helps lower LDL cholesterol in adults with high cholesterol, including heterozygous familial hypercholesterolemia. Administered via monthly subcutaneous injection, Lerochol can be stored at room temperature for up to 3 months. Common side effects include reactions at the injection site and cold-like symptoms.

And finally, we present Breyanzi, spelled B-R-E-Y-A-N-Z-I, with an expanded approval to include relapsed or refractory marginal zone lymphoma in patients who have received at least two prior lines of treatment. Breyanzi, a CAR T cell therapy from Bristol Myers Squibb, is a personalized treatment that transforms a patient's own T cells to attack cancer cells effectively, although potential risks like Cytokine Release Syndrome and neurological symptoms require careful oversight from healthcare professionals.

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.