The U.S. Food and Drug Administration
(FDA) has approved Lexicon Pharmaceuticals Inc’s drug
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for a broad treatment of heart failure, including in adult
patients with type 2 diabetes, the company said on Friday.
Shares of the company rose 13% in extended trading.
The oral drug, sotagliflozin, is the company’s first to be
approved by the U.S. health agency and will be sold under the
brand name Inpefa. It had previously failed to win U.S. approval
as an add-on to insulin therapy for type 1 diabetes.
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Sotagliflozin belongs to a class of medicine that helps
regulate blood glucose levels and reduce the risk of weight gain
by inhibiting SGLT1 and SGLT2 proteins.
Jardiance, a drug developed by Eli Lilly and
Boehringer Ingelheim that belongs to the same class, has
already been approved
by the U.S. regulator for the same indication.
Lexicon, which plans to launch the drug by the end of
June, said the medicine’s wholesale price is expected to be on
par with existing branded heart failure medications.
The current list price of Lilly’s Jardiance, the drug’s
main competitor, is $570.48 for a month’s supply.
Sotagliflozin presents a unique proposition in heart
failure, especially considering the drug’s differentiated
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benefit in hospitalized patients, compared with existing
treatments, Piper Sandler analyst Yasmeen Rahimi said ahead of
the approval.
Rahimi estimates the drug to rake in sales of $112
million by 2025 and about $576 million by 2028.
Lexicon partnered with French drugmaker Sanofi SA
to develop the drug. However, Sanofi later parted
ways with Lexicon after
paying a $260 million termination fee.
The FDA approval was based on a late-stage study that
showed the drug, when compared with a placebo, reduced the risk
of cardiovascular death and hospitalization due to heart failure
in adults with type 2 diabetes or certain other health
conditions.
(Reporting by Khushi Mandowara and Mariam Sunny in Bengaluru;
Editing by Shailesh Kuber and Anil D’Silva)
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