The latest in Obesity & Metabolic Disease Recommendations
As global attention intensifies on obesity and metabolic diseases, 2025 marks a watershed moment. Medical regulators, including the FDA, EMA, and other leading scientific authorities, have released transformative updates to policy, new drug recommendations, and clinical best practices.
FDA’s Major Policy Updates on Obesity Medications
The FDA’s 2025 guidance reflects the culmination of years witnessing surging demand for weight-management drugs such as GLP-1 receptor agonists, namely semaglutide and tirzepatide. With shortages now resolved as of early 2025, the FDA has phased out the emergency “enforcement discretion” that temporarily permitted the compounding of these drugs. After May 22, 2025, compounded versions of GLP-1s are no longer available, except for rare exceptions defined by law. This change directs all patients and providers to FDA-approved, branded injections from certified pharmacies for continued therapy.
The agency has also warned sternly against “research use” or mislabeling of GLP-1 derivatives, stepping up enforcement around dosing errors and purity. Patients are encouraged to verify their medications and avoid non-regulated sources, a move aligned with broader quality and safety measures.
New Eligibility Recommendations for GLP-1 Therapy
FDA’s latest eligibility guidance is pushing forward a more individualized strategy rooted in scientific evidence:
- BMI remains the standard screening cutoff: Patients with BMI ≥ 30 kg/m² (or ≥ 27 kg/m² with weight-related comorbidities) can be considered for therapy. However, there is acknowledgment of BMI’s limitations, and calls for more holistic focus on long term sustained weight management.
- Insurance coverage expanding but inconsistent: Many carriers—including Medicare and Medicaid—are broadening coverage for name-brand GLP-1s, though requirements such as prior authorization, confirmed BMI thresholds, and documented failure of lifestyle interventions persist. Advocacy continues for more universal access.
EMA: Innovation in Metabolic & Obesity Drug Approvals
Across the Atlantic, the European Medicines Agency (EMA) has accelerated approvals for biosimilars and first-in-class therapeutics targeting metabolic disease in 2025:
- The EMA authorized Rezdiffra (resmetirom) as the first approved treatment for noncirrhotic MASLD (metabolic-associated steatohepatitis), marking a milestone in direct intervention for fatty liver tied to obesity.
- A flurry of biosimilars (especially denosumab and ustekinumab) entered the market for conditions connected to obesity, such as osteoporosis and chronic inflammation. These biosimilar approvals help foster accessibility and drive down costs across Europe.
- Conditional approvals and expedited extensions for drugs targeting weight-related comorbidities are now common, signaling a regulatory emphasis on holistic metabolic health.
National Agency Perspectives & Global Targets
National health agencies (e.g., CMS, NHS, and others) are harmonizing obesity care policy, typically alongside international best practices. The Centers for Medicare & Medicaid Services (CMS) in the U.S., for example, is considering expanded coverage rules for weight management, mirroring FDA recommendations. However, as the World Obesity Federation’s recent report notes, only a few countries are on track to halt the rise in adult obesity by 2025. Most national strategies now prioritize integrated care over isolated pharmacological interventions.
Obesity & Metabolic Disease: Clinical Best Practices in 2025
In parallel with regulatory change, clinical guidelines have seen subtle but meaningful shifts this year:
- Integrated lifestyle and pharmacology: The strongest outcomes come from combining behavioral, nutritional, and pharmacologic strategies. Initiation of GLP-1 therapy is often paired with personalized dietary and activity coaching, with close attention to long-term maintenance and relapse prevention.
- Monitoring and safety: Standard protocols require careful titration, monitoring for adverse events (such as GI disturbances or mood changes), and periodic assessment of weight-related comorbidities (e.g., glycemic control, blood pressure). The use of pre-filled pens instead of unregulated vials is now the norm for safety.
- Focus on outcomes: Recent guidelines recommend tracking clinically meaningful weight reduction (≥10%, often ≥15%) and improvements in physical function or other metabolic endpoints. The move away from a simplistic five-percent threshold allows for more nuanced patient-centered care.
- Emphasis on patient education: Providers must educate patients about the importance of medication source verification and the risks of compounded or misbranded drugs, especially as more online sources proliferate.
The Future: Integrated, Patient-Centered Policy
The regulatory environment in 2025 places new demands on innovation, collaboration, and data sharing among stakeholders. Prism Labs sees these changes as an opportunity to improve outcomes by facilitating:
- Early identification of high-risk patients using easily accessible metabolic health metrics.
- Support for care transitions between primary, specialty, and behavioral health providers.
- Continuous physical health tracking via routine body scans during treatment.
Expert Takeaways for Stakeholders
For providers:
- Stay updated on evolving eligibility cutoffs and insurance criteria.
- Choose branded, FDA- or EMA-approved therapies for GLP-1s; compounded options are strictly limited.
- Continuously engage patients in lifestyle support and medication adherence.
For payers and policymakers:
- Develop transparent coverage policies based on updated BMI and metabolic outcomes criteria.
- Monitor post-market safety and efficacy of new agents, with special attention to health disparities.
For patients:
- Seek care with board-certified specialists.
- Understand requirements and documentation for insurance coverage before filling prescriptions.
- Utilize only approved medications via regulated pharmacies or clinics.
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