FDA makes end of Zepbound, Mounjaro shortage official

Dive Brief:

  • Shortages affecting the availability of Eli Lilly’s top-selling diabetes and weight-loss drugs have now been resolved, the Food and Drug Administration said Wednesday.
  • Lilly has assured regulators that product availability and manufacturing capacity is enough to meet both current and projected demand in the U.S., the FDA said. The drugs, sold as Mounjaro and Zepbound, are both made from the active ingredient tirzepatide, which has been on the FDA’s shortage list for almost two years.
  • The FDA’s announcement comes two months after the drugs were marked as “available” in the agency’s database. On Wednesday, the FDA put compounders on notice that the official resolution of the shortage means legal restrictions on making copies of the drugs will be back in place.

Dive Insight:

Mounjaro and Zepbound are part of the GLP-1 class of drugs that also includes Novo Nordisk’s Ozempic and Wegovy. The medicines’ powerful effects in fighting obesity, and many other related health problems, have supercharged a market that analysts say could reach $100 billion or more by 2030.

But demand for the new medications has far outstripped supply. Both Lilly and Novo Nordisk have been frantically working to increase production, with Lilly announcing a $5 billion investment in manufacturing capacity for the drugs in May.

While the drugs faced shortages, direct-to-consumer operators stepped in, taking advantage of rules that allow compounding pharmacies to make medicines with supply issues. Now that the shortage for Lilly is over, the FDA on Wednesday warned that facilities can’t make compounded drugs that simply copy agency-approved ones.

However, the law does allow exemptions in certain cases, including for compounded drugs that are personalized for a specific patient. And executives at one of the leading companies that relies on compounding, Hims and Hers, see that exception as a path for continued business.

“Our personalization dosages that exist on the platform today are offering fantastic high-touch care to patients that otherwise really wouldn’t be able to experience the benefits of GLP-1,” CEO Andrew Dudum told analysts on a conference call in August. “And I would expect in the future, in a post-shortage world, this also continues to exist for patients as an access point.”

Hims and Hers currently offer compounded versions of semaglutide, the active ingredient in Ozempic and Wegovy. The FDA’s database continues to list semaglutide in shortage.

The FDA warned consumers that there may still be local interruptions in supply of Mounjaro and Zepbound as manufacturers and distributors move the medicine to pharmacies around the country. Lilly has also warned patients of potentially “choppy” availability as shortages ease.