WSJ : Eli Lilly’s Zepbound Gets FDA OK for Multi-Dose Pen

Eli Lilly’s Zepbound Gets FDA OK for Multi-Dose Pen
Multi-dose pen will deliver four weekly injections from a single device

  • Eli Lilly received Food and Drug Administration approval for a Zepbound label expansion, adding a monthly delivery option.
  • The pharmaceutical company will offer Zepbound in a multi-dose pen at the same $299 monthly self-pay price via LillyDirect.
  • Zepbound is approved for chronic weight management and obstructive sleep apnea; patients lost 20.9% body weight over 72 weeks.

Eli Lilly LLY 5.15%increase; green up pointing triangle received approval from the Food and Drug Administration for a label expansion of its weight-loss drug Zepbound, adding a new monthly delivery option for patients.

The pharmaceutical company said Monday that the expansion allows Zepbound to be offered in a multi-dose pen that delivers four weekly injections from a single device. The obesity treatment had previously been available in single-dose vials.

Eli Lilly said the drug will be available at the same self-pay price in either the multi-dose pen or single-dose vial format, starting at $299 a month for the 2.5-milligram starter dose through LillyDirect, the company’s direct-to-consumer platform.

Zepbound is approved for chronic weight management in adults with obesity, or adults who are overweight with at least one weight-related condition. The drug is also approved to help treat moderate-to-severe obstructive sleep apnea in adults with obesity.

Lilly said demand for Zepbound reflects its efficacy, citing clinical trial data showing patients taking the 15-milligram dose lost an average of 20.9% of body weight over 72 weeks, compared with 3.1% for patients receiving placebo.