Eli Lilly and Company
) and partner Boehringer Ingelheim announced that their type II
diabetes candidate, empagliflozin, has received a positive
opinion from the European Medicines Agency's Committee for
Medicinal Products for Human Use (CHMP).
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The CHMP recommended approval of empagliflozin , an
investigational sodium glucose co-transporter-2 (SGLT2)
inhibitor, as an adjunct to diet and exercise to improve glycemic
control in patients suffering from type II diabetes. A final
decision should be out by May 2014.
In contrast, the U.S. Food and Drug Administration (FDA) issued a
Complete Response Letter (CRL) for empagliflozin earlier this
month. In the CRL, the FDA mentioned 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. However,
the FDA did not ask the companies to conduct additional studies.
The companies are working with the FDA to submit a response to
the CRL as soon as possible.
We are pleased with the positive CHMP recommendation for
empagliflozin considering several key products at Eli Lilly
including Cymbalta and Zyprexa are facing stiff generic
competition. A generic version of Evista will also be launched
However, if approved, empagliflozin will be a late entrant in the
diabetes market, with other SGLT2 inhibitors like
Johnson & Johnson
) Invokana and
) Forxiga already approved in the EU.
Eli Lilly carries a Zacks Rank #3 (Hold). A better-ranked stock
in the pharma sector is
Salix Pharmaceuticals Ltd.
) with a Zacks Rank #1 (Strong Buy).