Eli Lilly and Company
) and partner Boehringer Ingelheim announced that the European
Commission (EC) has approved their sodium glucose co-transporter-2
(SGLT2) inhibitor, Jardiance (empagliflozin). Jardiance (10 mg and
25 mg once daily tablets) is approved as an adjunct to diet and
exercise for improving glycemic control in adults suffering from
type II diabetes. Eli Lilly intends to launch Jardiance in the EU
in the third quarter of 2014.
We remind investors that in Apr 2014, empagliflozin was first
approved in Australia under the trade name Jardiance.
Jardiance can be used as a monotherapy in patients unable to
tolerate metformin. Alternatively, it can be used in combination
with other glucose-lowering medicines such as insulin, in case of
inadequate glucose control.
While EU approval was largely expected, considering a positive
opinion issued by the Committee for Medicinal Products for Human
Use (CHMP) in late March, Jardiance's regulatory path in the U.S.
has not been as smooth. In Mar 2014, Jardiance received a complete
response letter (CRL) from the U.S. Food and Drug Administration
(FDA) − the agency said that previously observed deficiencies at
the Boehringer Ingelheim facility where empagliflozin will be
manufactured need to resolved for approval.
On a positive note, the FDA did not ask the company to conduct
additional studies. Boehringer Ingelheim is waiting for feedback
from the FDA and continue to expect US regulatory action in 2014.
We note that the U.S. market already has SGLT2 inhibitors in the
Johnson & Johnson's
Additionally, a fixed-dose combination of empagliflozin and
Tradjenta is under FDA review for the treatment of adults suffering
from type II diabetes. Lilly has another candidate, dulaglutide,
under review in the EU for this indication.
The EU approval of Jardiance comes as a major positive for Eli
Lilly. Currently, Eli Lilly is facing a major challenge in the form
of loss of exclusivity for Zyprexa and Cymbalta and needs to bring
new products to market. However, the Animal Health business should
provide some downside support.
We are encouraged by Eli Lilly's decision to acquire
) animal health business to strengthen its Animal Health division.
We are also pleased to see Eli Lilly pursuing small acquisitions
and in-licensing deals to boost its pipeline.
(We are reissuing this article to correct a mistake. The
original article, issued yesterday, May 27, 2014, should no longer
be relied upon.)
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