1. FDA Approves Pfizer–BioNTech’s COMIRNATY® COVID-19 vaccine
On Aug 27, 2025, Pfizer and BioNTech announced that their LP.8.1-adapted monovalent COVID-19 vaccine, COMIRNATY®, has been approved by the U.S. FDA for adults aged 65 and older, as well as for individuals aged 5–64 with underlying health conditions that increase their risk of severe COVID-19. The FDA approval is based on the cumulative body of evidence showing acceptable safety and efficacy.
2. Leqvio® Achieves Strong LDL-C Reductions in Phase IV V-DIFFERENCE Study
On Aug 30, 2025, Novartis announced positive results from V-DIFFERENCE, a Phase IV study evaluating Leqvio® (inclisiran) compared to placebo in patients with high cholesterol (hypercholesterolemia) addition to their individual lipid-lowering therapy. Leqvio® (inclisiran) is the first and only small interfering RNA (siRNA) therapy to lower low-density lipoprotein cholesterol (LDL-C). After 90 days of treatment, 85% of patients achieved guideline-recommended LDL-C levels compared to 31% of those receiving placebos. The benefits were able to be monitored in 81% of patients at 30 days.
3. FDA Approves Sanofi’s Wayrilz™ (rilzabrutinib) for Chronic Immune Thrombocytopenia
On Aug 29, 2025, Sanofi announced that the U.S. FDA has approved Wayrilz (rilzabrutinib) for adults with persistent or chronic immune thrombocytopenia (ITP) showing insufficient response to past treatments. ITP is an autoimmune disorder where the immune system attacks the platelets, leading to a low platelet count with increased risk of bleeding. Wayrilz is a BTK inhibitor targeting different pathways in the immune system.
The approval was based on the positive results from the LUNA 3 phase 3 study. In the trial, Wayrilz met the primary and secondary endpoints, maintaining platelet counts and controlling other ITP symptoms. At week 25, 23% of patients in the Wayrilz arm showed a significant platelet response, while there was no observation in the placebo arm.
Link: https://www.sanofi.com/en/media-room/press-releases/2025/2025-08-29-21-50-18-3141825
4. AstraZeneca’s Baxdrostat Lowers Blood Pressure in Hard-to-Control Hypertension
On Aug 30, 2025, AstraZeneca announced that its oral aldosterone synthase inhibitor baxdrostat met the primary and all secondary endpoints in the Phase III BaxHTN trial. At 12 weeks, baxdrostat significantly lowered systolic blood pressure (SBP) versus placebo. The 2 mg dose reduced SBP by 15.7 mmHg from baseline and by 9.8 mmHg more than placebo. The 1 mg dose lowered SBP by 14.5 mmHg from baseline and by 8.7 mmHg versus placebo. The drug was generally well tolerated, with a safety profile consistent with earlier studies..
5. Eli Lilly’s Orforglipron Achieves Significant Weight Loss and A1C Reduction in Phase 3 ATTAIN-2 Trial
On Aug 26, 2025, Eli Lilly and Company announced positive topline results from the Phase 3 ATTAIN-2 trial, evaluating orforglipron (GLP-1 receptor agonist) in adults with obesity or overweight and type 2 diabetes. In the trial, all three doses of orforglipron met the primary and all key secondary endpoints. For the primary endpoint, orforglipron 36 mg, lowered weight by an average of 10.5% (22.9 lbs) compared to 2.2% (5.1 lbs) with placebo. In a key secondary endpoint, the A1C level has been lowered from 8.1% to 1.3% to 1.8%. Moreover, 75% of the participants who took the highest dose of orforglipron achieved an A1C ≤6.5%.
6. FDA Expands Repatha® Label to High-Risk Adults With Uncontrolled LDL-C
On Aug 25, 2025, Amgen announced that the U.S. FDA had expanded the approval for Repatha® (evolocumab) to use for adults at increased risk for major adverse cardiovascular events (MACE) due to uncontrolled LDL cholesterol. The expanded label broadens Repatha’s use beyond patients with established cardiovascular disease or familial hypercholesterolemia, allowing physicians to prescribe it earlier for high-risk individuals.
7. Wegovy® Shows Superior Real-World Cardiovascular Outcomes vs. Tirzepatide in STEER Study
On Aug 31, 2025, Novo Nordisk revealed findings from the real-world STEER study, which compared cardiovascular outcomes in individuals with obesity and established cardiovascular disease (CVD) treated with Wegovy® (semaglutide 2.4 mg) versus their major competitor, tirzepatide. In patients without treatment gaps longer than 30, Wegovy® was associated with a 57% greater reduction in major adverse cardiovascular events (MACE)—including heart attack, stroke, and death—compared to tirzepatide (0.1% vs. 0.4% incidence). Across all treated individuals, regardless of treatment continuity, Wegovy® also demonstrated a 29% lower risk of heart attack, stroke, or death compared to tirzepatide.
8. Teva Launches First FDA-Approved Generic GLP-1 With Saxenda® (Liraglutide) Injection
On Aug 28, 2025, Teva Pharmaceuticals announced that the U.S. FDA had approved and launched the first generic version of Saxenda® (liraglutide injection), marking the first FDA-approved generic GLP-1 therapy. The product is indicated for weight loss in adults with obesity or overweight (excess weight) who also have weight-related medical problems.
9. Phase 3 Success for Cemdisiran with or without Pozelimab in Generalised Myasthenia Gravis
On Aug 26, 2025, Regeneron announced positive results from its Phase 3 trial of cemdisiran combined with or without pozelimab in patients with generalised myasthenia gravis (gMG). Cemdisiran is an siRNA that reduces circulating levels of complement factor 5. The study met its primary endpoint, showing a statistically significant and clinically meaningful improvement in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score at Week 24 compared with placebo. Key secondary endpoints were also achieved, including improvements in Quantitative Myasthenia Gravis (QMG) scores and quality-of-life measures. The treatment was generally well tolerated, with a safety profile consistent with prior studies. Cemdisiran monotherapy showed a 2.3-point placebo-adjusted improvement, and cemdisiran-pozelimab combination showed 1.74 placebo-adjusted improvement.
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