Novartis expected to be in the market this year with Galvus, But the FDA is requiring more studies to determine Galvus’s safety, so they will not resubmit until probably mid-2009
The experimental diabetes drug Galvus has been recommended for approval in Europe, lifting prospects for a medicine that faces a lengthy delay in getting to market in the United States.
Thursday’s decision by a committee of experts at the European Medicines Agency comes two days after Novartis said it would not be ready to resubmit Galvus to U.S. regulators until mid-2009, following a request for more safety data.
Novartis said the agency’s Committee for Medicinal Products for Human Use (CHMP) had also backed its Exelon Patch, which delivers a treatment for Alzheimer’s disease through a skin patch, and once-yearly Aclasta for women with postmenopausal oesteoporosis.
Recommendations for marketing approval by the agency’s Committee for Medicinal Products for Human Use are normally endorsed by the European Commission. Novartis said it expected to get a final decision on Galvus within three months.
Galvus works in a similar way to Merck & Co. Inc. recently launched Januvia product but its path to market has been delayed by worries over skin toxicity.
Both Galvus and Januvia are so-called DPP-4 inhibitors, which are designed to enhance the body’s own ability to lower elevated blood sugar and could become an important new way to control type 2 diabetes — the most common form of the disease.
The drugs’ manufacturers and many analysts believe DPP-4 drugs could become blockbusters because they are not associated with weight gain, a major side effect of some established diabetes drugs.
Galvus is being recommended in the European Union for use in combination with other common oral diabetes medicines — metformin, a thiazolidinedione (TZD) or a sulfonylurea (SU).
"Many type 2 diabetes patients need more than one treatment to bring their blood sugar levels under control, therefore the efficacy and tolerability of Galvus in combination with other medicines is especially significant," Novartis’s global head of pharma development, James Shannon, said in a statement.
Galvus is already available in Brazil and Mexico.
DID YOU KNOW:
Half of Diabetic Patients Not Reaching HbA1c Target: Despite significant gains in disease control over the last 6 years, nearly half of patients with diabetes failed to reach national treatment goals in 2006. An analysis of 22.7 million hemoglobin A1c tests performed on 4.8 million patients with diabetes mellitus at Quest Labs revealed that as of December 2006, 55% of patients had reached the American Diabetes Association (ADA) treatment target of hemoglobin A1c levels less than 7%. This compares with 38% of patients in 2001. See this week’s Item #8
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