FDA approves Eli Lilly's once-a-week insulin injection for type 2 diabetes treatment

The FDA approved Eli Lilly's Onswik, a once-weekly basal insulin, for adults with type 2 diabetes. The approval is based on four phase 3 studies showing its efficacy in controlling glucose levels. Onswik is the second such insulin approved by the FDA, following Novo Nordisk's Awiqli. Lilly plans to launch the Onswik KwikPen in the U.S. in the coming months.

Eli Lilly (LLY) shares rose 3.4% after FDA approved its once-weekly insulin, Onswik, for type 2 diabetes. The drug, shown effective in trials, reduces injections by over 300 per year. Lilly's stock is near its 52-week high, up 10.3% YTD. The company reported strong Q4 2025 results and upbeat 2026 forecasts, driven by weight-loss and diabetes drugs.

The FDA warned Empower Pharmacy for allegedly mass-producing copies of patented weight-loss drugs, violating federal law. Empower disputes the claims and says it is cooperating. The FDA's action may impact the availability of cheaper compounded versions of GLP-1 drugs, affecting Novo Nordisk and Eli Lilly, which market these drugs.

Eli Lilly (LLY) received FDA approval for Onswik, a once-weekly insulin for type 2 diabetes, based on successful clinical trials. The drug showed comparable efficacy to daily treatments. Separately, Lilly signed a $3.25 billion deal with InnoCare Pharma for drug development. LLY shares rose 3.42% to $1,190.32.

The FDA approved Eli Lilly's (LLY) once-weekly insulin Onswik for type 2 diabetes. The drug, already approved in the EU, Mexico, and Japan, aims to reduce injections from 365 to 52 per year. Despite the approval, LLY shares dipped 1.6%. Lilly's revenue and net income have surged, reaching $22.97bn and $7.1bn respectively in Q2 2026. The company faces competition from Novo Nordisk's Awiqli in the weekly insulin market.

InnoCare Pharma and Eli Lilly entered a $3.35 billion research and license agreement. InnoCare may receive up to $100 million upfront and $3.25 billion in milestones. The deal focuses on discovering and advancing compounds for unmet medical needs. Eli Lilly has been active in dealmaking this year, acquiring multiple companies.