Shots:
- Approval activity continued strongly into April 2026, with the US FDA authorizing two significant therapies across metabolic disease and infectious disease, reinforcing the agency’s focus on chronic disease management, long-term treatment innovation, and broader patient access.
- Two notable therapies achieved regulatory clearance: Eli Lilly’s Foundayo for weight loss in obese or overweight adults with weight-related conditions, and Merck’s Idvynso for virologically suppressed HIV-1 infection as a switch treatment option.
- Overall, April 2026 highlighted sustained FDA momentum in advancing therapies for high-burden chronic conditions, spanning obesity management and HIV care, while emphasizing improved clinical outcomes, simplified treatment approaches, and expanded global access strategies.
Company: Eli Lilly
Product: Foundayo
Active Ingredient: Orforglipron
Disease: Weight Loss
Date: Apr 01, 2026
Shots:
- FDA has approved Foundayo along with lifestyle intervention for obese/overweight adults with weight-related medical problems; Foundayo will be available via LillyDirect beginning Apr 6, 2026
- Approval was backed by the ATTAIN program, incl. ATTAIN-1, where Foundayo showed weight loss of 27.3 lbs (12.4%) vs 2.2 lbs (0.9%) with PBO at highest dose, with overall loss of 25 lbs (11.1%) vs 5.3 lbs (2.1%), alongside reductions in CV risk markers across all doses
- Eli Lilly aims to improve access to Foundayo with pricing from $25/month (insured), $149/month (self-pay), & ~$50/month for eligible Medicare Part D pts (from Jul 2026), while advancing filings in 40+ countries for weight management & T2D, with launch shortly after approval
Company: Merck
Product: Idvynso
Active Ingredient: Doravirine and Islatravir
Disease: Virologically Suppressed HIV-1 Infection
Date: Apr 20, 2026
Shots:
- The US FDA approved Idvynso (100mg doravirine/0.25mg islatravir; QD, PO) to treat HIV-1 in virologically suppressed adults (HIV-1 RNA <50 copies/mL) as a switch option for those on stable regimens with no prior treatment failure or doravirine resistance
- Approval was supported by the P-III trials, incl. Trial 052 (n=513), where pts switched from BIKTARVY to Idvynso or stayed on therapy, & Trial 051 (n=551), where oral ART-treated pts switched to Idvynso or remained on the same regimen
- In Trial 052, 1% on Idvynso (n=342) vs 1% on BIKTARVY (n=171) had HIV-1 RNA ≥50 copies/mL at Wk. 48, with 92% vs 94% maintaining suppression; in Trial 051, 1% on Idvynso (n=366) vs 5% on bART (n=185) had ≥50 copies/mL, with 96% vs 92% maintaining suppression. Results were consistent across all subgroups
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