Study shows Galvus less effective than generic: Novartis
Novartis lowered expectations for an experimental diabetes compound Galvus but submitted a bone and a cancer drug to regulators ahead of schedule.
Galvus (vildagliptin), a once-daily oral treatment for patients with type 2 diabetes, proved less effective than standard treatment in a two-year trial, the company said in a written update of its pipeline issued this week. The drug was slightly less effective than metformin, the generic drug for the disease.
Based on the results, “The potential of [Galvus] will be significantly reduced,” an analyst told the Associated Press.
The news was not the first setback for Galvus. Earlier this month Novartis extended the review period for the highly anticipated drug, pushing its expected approval back to the first half of 2007.
Some analysts had predicted a major marketing duel between Galvus and Merck’s recently approved diabetes pill, Januvia. Both are part of a new class of drugs known as DPP-4 inhibitors, which enhance the body’s ability to lower elevated blood sugar. Januvia was launched this fall.
Development of a cancer drug is also progressing slower than planned, because the company has not been able to recruit patients fast enough for a clinical trial.
Novartis also said it filed US and EU regulatory applications for Tasigna (nilotinib), for certain patients with resistance and/or intolerance to Gleevec/Glivec, and for Aclasta/Reclast, a once-yearly drug for women with postmenopausal osteoporosis. Both filings were completed ahead of schedule, the company said.
Novartis said it now has 138 projects in clinical development, including 94 projects at phase IIb or later, in key areas such as cardiovascular/metabolic conditions, oncology and neuroscience, as well as respiratory and infectious diseases.
In addition to Galvus, Novartis expects US regulatory decisions for Tekturna (aliskiren), a renin inhibitor for hypertension, and Exforge (valsartan and amlodipine), a single-tablet combination of hypertension medicines.
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