Eli Lilly and Company
) and partner Boehringer Ingelheim suffered a regulatory setback
with the U.S. Food and Drug Administration (FDA) issuing a
Complete Response Letter (CRL) for their New Drug Application
(NDA) for empagliflozin, investigational sodium glucose
co-transporter-2 (SGLT2) inhibitor. Eli Lilly and Boehringer
Ingelheim are looking to get the candidate approved for the
treatment of type II diabetes.
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The FDA mentioned in the CRL that the deficiencies observed
previously at the Boehringer Ingelheim manufacturing facility,
where empagliflozin will be produced, have to be resolved in
order to gain approval for the candidate. Importantly, the agency
did not ask the companies to conduct additional studies.
Eli Lilly and Boehringer Ingelheim said that they are working
with the FDA to submit a response to the CRL and resolve the
issues mentioned in it.
The delay in FDA's decision on empagliflozin, while
disappointing, is not really surprising as the Boehringer
Ingelheim manufacturing facility had already received a warning
letter from the FDA and chances remained that this would delay
the approval of empagliflozin.
However, Eli Lilly needs to bring new products to market
considering key products like Cymbalta and Zyprexa are facing
stiff generic competition. A generic version of Evista will also
be launched shortly. Meanwhile, SGLT2 inhibitors like
Johnson & Johnson
's Invokana (
) Farxiga will get a head start in the type II diabetes market.
Eli Lilly carries a Zacks Rank #3 (Hold). A better-ranked stock
in the pharma sector is
) with a Zacks Rank #2 (Buy).