June 20 (Reuters) - U.S. drugmaker Eli Lilly ( LLY )
said on Thursday it was suing six more entities including
medical spas and wellness centers for selling products claiming
to contain tirzepatide, the active ingredient in its popular
diabetes drug, Mounjaro.
Tirzepatide was approved late last year as Zepbound for
weight loss, and Lilly is the only company that has the approval
of the U.S. Food and Drug Administration to sell the drug.
In its six separate lawsuits filed in the courts of
Ohio, Texas, Hawaii and the District of Columbia, Lilly has
alleged that these entities are falsely claiming that their
compounded versions of tirzepatide are approved by the FDA.
Lilly has warned that unsafe or untested compounded
tirzepatide puts patients at risk and said it was concerned
about the increasing number of online sales and posts on social
media involving counterfeit versions of its drug.
Demand has been outpacing supply for GLP-1 drugs, which
include Novo Nordisk's Wegovy and Lilly's Zepbound
and Mounjaro. Some doses of Mounjaro and Zepbound are expected
to be available in limited quantities through the second
quarter, according to the FDA.
Lilly and Danish rival Novo have sued several entities
to stop them from selling products claiming to contain the
active ingredients - tirzepatide and semaglutide - used in their
respective popular weight-loss drugs.
In May, the Indianapolis-based drugmaker entered into a
settlement deal with Totality Medispa, which was required to
make a monetary payment to Lilly and implement other corrective
measures.
Lilly has entered into similar settlements with other
med spas and wellness centers, which have falsely advertised
their products in the past, it said on Thursday.
The FDA has warned about the safety risks of using
compounded or custom-made versions of popular weight-loss drugs.
However, the agency's guidelines allow compounded drugs
to be made and distributed with fewer restrictions, under
certain circumstances, such as when the original drug appears on
its drug-shortage list.
(Reporting by Bhanvi Satija in Bengaluru; Editing by Anil
D'Silva)