The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) recently provided two positive
opinions for new indications of
) type II diabetes treatments - Galvus (vildagliptin) and Eucreas
(vildagliptin and metformin), along with other medications.
The first positive opinion was issued for Galvus plus insulin
but with or without metformin for the treatment of patients
diagnosed with type II diabetes, when diet, exercise and stable
insulin dosage failed to control the glycemic level.
The positive opinion was based on data from a randomized,
double-blind, 24-week study which showed that the 50 mg twice daily
dosage of Galvus when administered along with insulin but with or
without metformin resulted in a reduction in blood sugar levels
compared to placebo.
The second positive opinion was for the use of Eucreas in
combination with sulphonylurea when diet, exercise and the combined
therapy failed to achieve adequate glycemic control.
Data from a study revealed that the 50 mg twice daily dosage of
Eucreas in combination with sulphonylurea helped in the reduction
of blood sugar levels in a higher number of patients compared to
placebo (28.3% versus 5.6%).
According to the International Diabetes Federation, diabetes is
considered one of the world's biggest challenges in the healthcare
sector. It has already affected 366 million people worldwide and
results in the death of one person every seven seconds.
We note that Novartis' Galvus, already approved in more than 100
countries, recorded sales of $224 million in the second quarter of
2012, led by solid growth in Japan and in some parts of China,
Latin America and Asia Pacific. Approval of Galvus and Eucreas for
the additional indications in the EU would boost Novartis' top-line
Already approved treatments for type II diabetes include
Merck & Co.
) Januvia and
Bristol-Myers Squibb Company
) Byetta and Bydureon.
Currently, we have a Neutral recommendation on Novartis.
Novartis carries a Zacks #3 Rank (Hold rating) in the short
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